Your activity: 315 p.v.
your limit has been reached. plz Donate us to allow your ip full access, Email: sshnevis@outlook.com

Immune globulin (Intravenous, subcutaneous, and intramuscular): Drug information

Immune globulin (Intravenous, subcutaneous, and intramuscular): Drug information
(For additional information see "Immune globulin (Intravenous, subcutaneous, and intramuscular): Patient drug information" and see "Immune globulin (Intravenous, subcutaneous, and intramuscular): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Special Alerts
Expiration Date Extension for Asceniv June 2022

The FDA has approved an extension of the expiration date of ADMA Biologics' Asceniv (immune globulin) 10% liquid from 24 to 36 months when stored at 2 to 8°C (36 to 46°F). The new expiration date is valid for 6 Asceniv lots that were manufactured and distributed in 2019 and 2020. Future lots will be labeled according to the new dating period.

Further information, including the impacted lots, may be found at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/expiration-date-extension-6-asceniv-immune-globulin-intravenous-human-slra-10-liquid-lots.

Expiration Date Extension for Bivigam May 2022

The FDA has approved an extension of the expiration date of ADMA Biologics’ Bivigam (immune globulin) intravenous liquid 10% from 24 to 36 months when stored at 2 to 8°C (36 to 46°F). The new expiration date is valid for 120 Bivigam lots that were manufactured and distributed in 2020 to 2022. Future lots will be labeled according to the new dating period.

Further information, including the impacted lots, may be found at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/expiration-date-extension-120-bivigam-immune-globulin-intravenous-human-10-liquid-lots-manufactured.

Withdrawal of Select Immune Globulin Intravenous and Subcutaneous Products March 2022

The FDA along with manufacturers of affected products have voluntarily withdrawn certain lots of immune globulin intravenous (IGIV) and immune globulin subcutaneous (IGSC) due to a higher rate of allergic/hypersensitivity-type reactions, some clinically significant.

Further information on affected products and lot numbers is available at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/voluntary-lot-withdrawals-immune-globulin-intravenous-igiv-and-immune-globulin-subcutaneous-igsc

Expiration Date Extension for Cutaquig January 2021

The FDA has approved an extension of the expiration date of Octapharma’s Cutaquig (immune globulin) subcutaneous injection from 24 to 36 months when stored at 2 to 8°C (36 to 46°F). The new expiration date is valid for 42 Cutaquig lots that were manufactured and distributed in 2019 to 2020. The 6-month shelf life for Cutaquig stored at room temperature up to 25°C (77°F) is unchanged, and the expiration date extension does not apply to lots of Cutaquig that have already been stored at 25°C.

For additional information and the list of lots, please refer to https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/expiration-date-extension-42-cutaquig-immune-globulin-subcutaneous-human-hipp-165-solution-lots.

ALERT: US Boxed Warning
Thrombosis:

Thrombosis may occur with immune globulin products. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Renal dysfunction and acute renal failure (excluding Cutaquig, Cuvitru, Hizentra, HyQvia, GamaSTAN, and Xembify):

Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur in predisposed patients with immune globulin intravenous (IGIV) products. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. (Note: The following IV products do not contain sucrose: Asceniv, Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam 5%, Octagam 10%, Panzyga, and Privigen.) For patients at risk of renal dysfunction or acute renal failure, administer IGIV products at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration.

Brand Names: US
  • Asceniv;
  • Bivigam;
  • Carimune NF [DSC];
  • Cutaquig;
  • Cuvitru;
  • Flebogamma DIF;
  • GamaSTAN;
  • Gammagard;
  • Gammagard S/D Less IgA;
  • Gammaked;
  • Gammaplex;
  • Gamunex-C;
  • Hizentra;
  • Hyqvia;
  • Octagam;
  • Panzyga;
  • Privigen;
  • Xembify
Brand Names: Canada
  • Cutaquig;
  • Cuvitru;
  • Gamastan S/D [DSC];
  • Gammagard;
  • Gammagard S/D;
  • Gamunex;
  • Hizentra;
  • IGIVnex;
  • Iveegam Immuno;
  • Octagam;
  • Panzyga;
  • Privigen
Pharmacologic Category
  • Blood Product Derivative;
  • Immune Globulin
Dosing: Adult

Note: Always administer each initial IV dose under medical supervision. Route of administration: Not all products are interchangeable with regard to route of administration; consult manufacturer labeling. Several intravenous immune globulin (IVIG) 10% formulations FDA-approved for IV administration only may be administered as a SUBQ infusion based on clinical judgment and patient tolerability. In contrast, do not give higher concentration SUBQ products (eg, 20% [Cuvitru, Hizentra, Xembify]) or IM products (eg, 16% [GamaSTAN {Canadian product}]) intravenously. Dosing: Dosage is expressed as mg/kg or mL/kg and is dependent upon route of administration; use extra caution to ensure accuracy. Product-specific dosing is provided where applicable. Pretreatment: Ensure adequate hydration when using formulations containing certain stabilizers (eg, sucrose) and for patients with risk factors for thrombosis and/or renal complications (eg, preexisting renal insufficiency, diabetes, >65 years of age, heart disease, paraproteinemia, concomitant nephrotoxic agents) (Ref). Many patients do not require premedication prior to receiving IVIG; however, some clinicians may consider administering premedication (eg, acetaminophen, a nonsteroidal anti-inflammatory drug, a glucocorticoid, and/or diphenhydramine), especially if there have been prior reactions or other reasons for special concern (Ref).

Antibody-mediated rejection, treatment

Antibody-mediated rejection, treatment (off-label use):

Note: Optimal dose, frequency, and duration are unknown and vary based on institutional protocols. Dose may require large volume of fluid. These are only example regimens; dosing is center dependent.

Heart transplantation: IV: 2 g/kg divided into 2 or 4 doses and given on consecutive days as part of an appropriate combination regimen; if plasmapheresis is utilized, administer 100 mg/kg after each session. Regimen may be re-dosed monthly, if necessary, based on response (Ref).

Kidney transplantation:

Antibody-mediated rejection <1 year after transplant: IV: 1 to 2.4 g/kg in divided doses over 1 to 3 consecutive days as part of an appropriate combination regimen (maximum total daily dose: 1 g/kg); with plasmapheresis, give 100 mg/kg after each session and remaining total dose after final session over 1 to 2 days (Ref).

Antibody-mediated rejection >1 year after transplant: IV: 200 mg/kg every 2 weeks for 3 doses as part of an appropriate combination regimen (Ref).

Lung transplantation: IV: 500 mg/kg to 2 g/kg as part of an appropriate combination regimen (doses >1 g/kg are typically divided into 2 doses and given over 2 days). This regimen may be re-dosed monthly, if necessary, based on response (Ref).

Antiviral prophylaxis

Antiviral prophylaxis:

Hepatitis A, prophylaxis (adjunctive agent):

Note: Hepatitis A vaccine alone is preferred for most individuals; IVIG may be administered in combination with hepatitis A vaccine (at a different anatomical site) in high-risk settings, or alone in individuals who are allergic to hepatitis A vaccine (Ref).

Preexposure prophylaxis upon travel into endemic areas (alternative agent) (GamaSTAN, GamaSTAN S/D [Canadian product]):

Anticipated risk of exposure <1 month: IM: 0.1 mL/kg (Ref).

Anticipated risk of exposure 1 to 2 months: IM: 0.2 mL/kg (Ref).

Anticipated risk of exposure ≥2 months: IM: 0.2 mL/kg every 2 months (Ref).

Postexposure prophylaxis (alternative agent) (GamaSTAN, GamaSTAN S/D [Canadian product]):

IM: 0.1 mL/kg given as soon as possible within 14 days of exposure and/or prior to manifestation of disease; not needed if at least 1 dose of hepatitis A vaccine was given at ≥1 month before exposure, unless patient has HIV infection (Ref).

Measles, prophylaxis:

Measles, preexposure prophylaxis in patients with primary humoral immunodeficiency at risk of measles exposure (eg, during an outbreak, travel to endemic area) who are currently receiving immune globulin therapy:

IV:

Patients receiving Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex 5%, Gammaplex 10%, Gamunex-C, Flebogamma DIF 5%, Flebogamma DIF 10%, Octagam 5%, or Privigen:

If prior routine dose is <400 mg/kg (Gammaked only) or <530 mg/kg (other products): Give at least 400 mg/kg (Gammaked only) or at least 530 mg/kg (other products) as soon as possible before expected exposure followed by resumption of prior dosing in 3 to 4 weeks.

Patients receiving Panzyga:

If prior dose <530 mg/kg: Increase dose to at least 530 mg/kg immediately before expected exposure; increased dose provides adequate serum level for at least 22 days.

If prior dose ≥530 mg/kg: Maintain current dose.

SUBQ:

Patients receiving Cutaquig:

If prior weekly dose <245 mg/kg: Increase dose to 245 mg/kg weekly.

If prior weekly dose ≥245 mg/kg: Maintain current dose.

Patients receiving Cuvitru:

If prior weekly (or weekly equivalent) dose <230 mg/kg: Increase dose to at least 230 mg/kg weekly or the weekly equivalent of 230 mg/kg for dosing intervals other than weekly.

Patients receiving Hizentra:

If prior dosing is weekly or more frequent: Ensure total weekly dose of ≥200 mg/kg for 2 consecutive weeks followed by resumption of prior dosing schedule.

If prior dosing is biweekly: Administer at least 400 mg/kg once followed by resumption of prior dosing schedule.

Measles, postexposure prophylaxis in patients with primary humoral immunodeficiency currently receiving SUBQ or IV immune globulin therapy; patients who are immunocompromised without evidence of immunity; and pregnant or severely immunocompromised patients without evidence of measles immunity (Ref):

IV: 400 mg/kg as a single dose as soon as possible and within 6 days of exposure (Ref). For patients with primary humoral immunodeficiency currently receiving SUBQ or IV immune globulin therapy, resume prior dosing schedule.

SUBQ (Hizentra only): 400 mg/kg as a SUBQ infusion as soon as possible and within 6 days of exposure followed by resumption of prior dosing schedule (Ref). Note: This regimen is generally used for patients with primary humoral immunodeficiency currently receiving Hizentra.

Varicella, postexposure prophylaxis (alternative agent):

Note: Varicella zoster immune globulin is preferred; IVIG may be used if varicella zoster immune globulin is unavailable (Ref).

IV: 400 mg/kg administered as a single dose within 10 days but, ideally, within 96 hours of exposure (Ref).

IM ( GamaSTAN, GamaSTAN S/D [Canadian product]) : 0.6 to 1.2 mL/kg once within 72 hours of exposure. Note: For patients at risk of thrombosis, administer at the lower end of the recommended dosage range (Ref).

Chronic inflammatory demyelinating polyneuropathy

Chronic inflammatory demyelinating polyneuropathy:

IV:

Initial: 2 g/kg administered in divided doses over 2 to 5 consecutive days (eg, 400 mg/kg once daily for 5 days) followed by maintenance dosing (maximum total daily dose: 1 g/kg) (Ref).

Maintenance: 1 g/kg administered as a single infusion over 1 day or divided into 2 doses over 2 consecutive days, every 3 weeks (Ref). Continue maintenance therapy for 2 to 3 months before determining response to therapy. Further tapering of dose or frequency and the duration of maintenance therapy are individualized depending upon clinical response (Ref).

SUBQ (alternative route): Note: May be used as maintenance therapy for patients who respond to initial IVIG therapy (Ref). Begin maintenance therapy 1 week after last IVIG infusion.

Maintenance: 200 to 400 mg/kg/week administered in 1 or 2 sessions over 1 or 2 consecutive days (Ref). For worsening symptoms, consider restarting IVIG using dosing above.

Dermatomyositis/Polymyositis, severe, life-threatening or refractory

Dermatomyositis/Polymyositis , severe, life-threatening or refractory:

Note: For dermatomyositis, use in combination with other agents (Ref).

IV: 1 g/kg per day on 2 consecutive days every 4 weeks (total monthly dose: 2 g/kg) (Ref). For patients who develop intolerable adverse effects, some experts give 1 g/kg per day once every 2 weeks. Dosing interval may be lengthened once complete clinical response is achieved (Ref).

SUBQ (alternative route): 500 mg/kg once weekly (total monthly dose: 2 g/kg) (Ref).

Duration: Full clinical effect may take up to 6 months. Relapse may occur upon treatment discontinuation; continued treatment may be necessary to maintain control (Ref).

Encephalomyelitis, acute disseminated

Encephalomyelitis, acute disseminated (off-label use):

Note: Reserve for patients in whom first-line therapy with high-dose glucocorticoids has failed while evaluating for alternative diagnoses (Ref).

IV: 400 mg/kg once daily for 5 days (Ref).

Guillain-Barré syndrome

Guillain-Barré syndrome (off-label use):

Note: Initiate IVIG within 4 weeks of symptom onset (Ref).

IV: 400 mg/kg once daily for 5 days (Ref). Re-treatment is not recommended due to increased risk of adverse effects without additional benefit (Ref).

Hypogammaglobulinemia, prophylaxis against bacterial infection

Hypogammaglobulinemia, prophylaxis against bacterial infection:

Acquired secondary to malignancy:

Note: Reserve for patients who have had recurrent infections and have a low serum IgG (eg, <300 to 500 mg/dL); routine prophylaxis not recommended and thresholds for treatment vary (Ref).

IV: Initial: 200 to 400 mg/kg given as a single dose once every 3 to 4 weeks. Adjust dose or frequency to maintain IgG concentration >500 to 700 mg/dL and/or based on response to therapy (Ref).

Hematopoietic cell transplantation (off-label use):

Note: Reserve for patients who have had recurrent infections and have a low serum IgG (eg, <300 to 500 mg/dL); routine prophylaxis not recommended and thresholds for treatment vary (Ref).

≤100 days post–hematopoietic cell transplantation: IV: 500 mg/kg administered as a single dose once weekly (Ref).

>100 days post–hematopoietic cell transplantation: IV: 500 mg/kg administered as a single dose every 3 to 4 weeks (Ref).

Note: Adjust dose or frequency to maintain IgG concentration >500 to 700 mg/dL and/or based on patient's response to therapy (Ref).

Primary humoral immunodeficiency disorders:

IV: 400 to 600 mg/kg as a single dose once every 3 to 4 weeks; adjust dose based on clinical condition and response (see "Note" below). Dosage range: 200 to 800 mg/kg (Ref). Consider using lower concentrations (eg, Carimune NF 3%) in previously untreated patients; may use higher concentrations if tolerated.

SUBQ: 100 to 200 mg/kg once weekly; adjust dose based on clinical condition and response (see "Note" below). Dosage range: 200 to 800 mg/kg (Ref). May facilitate absorption by administering along with hyaluronidase (Ref).

HyQvia: See manufacturer's labeling for initial ramp-up schedule (initiating treatment with a full monthly dose has not been evaluated).

Note: Consistent IgG trough concentrations are typically achieved after 3 to 6 months of regular therapy. Adjust dose to maintain goal IgG trough 500 to 800 mg/dL; occasionally, a goal of >1 g/dL is required (Ref). Refer to "Switching from IV to SUBQ infusion dosing or switching between SUBQ products" below for dosing and administration recommendations when switching between products.

Immune thrombocytopenia

Immune thrombocytopenia:

Immune thrombocytopenia (adjunctive or alternative agent):

Note: For patients who require a rapid increase in platelet count, those who do not respond to glucocorticoids, and those who cannot tolerate glucocorticoids. IVIG may also be used for patients with critical bleeding or a need for urgent surgery or procedures (eg, pregnancy) (Ref).

IV: 1 g/kg once daily for 1 or 2 days; second dose may be withheld if adequate platelet response (eg, platelets >50,000/mm3) in 24 hours (Ref). Alternative dosing: 400 mg/kg once daily for 5 days (Ref).

Fetal and neonatal alloimmune thrombocytopenia (maternal administration): IV: 1 to 2 g/kg per week, with or without glucocorticoids (doses >1 g/kg are typically divided into 2 doses and given over 2 days). Dose is dependent upon gestational age and risk (Ref).

Lambert-Eaton myasthenic syndrome

Lambert-Eaton myasthenic syndrome (off-label use): IV: 2 g/kg administered in divided doses over 2 to 5 consecutive days (eg, 400 mg/kg once daily for 5 days) (maximum total daily dose: 1 g/kg) (Ref). For patients who respond to initial therapy, IVIG may be repeated every 4 to 12 weeks for symptom recurrence (Ref).

Multifocal motor neuropathy

Multifocal motor neuropathy:

Initial: IV: 2 g/kg administered in divided doses over 2 to 5 consecutive days (eg, 400 mg/kg once daily for 5 days) (maximum total daily dose: 1 g/kg) (Ref).

Maintenance: Note: Dosing is individualized and based on clinical response.

IV: 1 to 2 g/kg every 2 to 6 weeks. If initial dose was administered over 5 days and was well tolerated, maintenance dose may be administered over a shorter duration (eg, total dose of 2 g/kg administered as 1 g/kg daily for 2 consecutive days) (Ref).

Myasthenia gravis, acute exacerbation

Myasthenia gravis, acute exacerbation (off-label use): IV: 2 g/kg per treatment course, administered in divided doses over 2 to 5 consecutive days (eg, 400 mg/kg once daily for 5 days or 1 g/kg once daily for 2 days) (maximum total daily dose: 1 g/kg) (Ref). Note: A single dose of 1 g/kg may have similar efficacy to 1 g/kg given on 2 consecutive days (Ref).

Parvovirus B19 infection, treatment, immunocompromised host

Parvovirus B19 infection, treatment, immunocompromised host (off-label use):

Solid organ transplant: IV: 400 mg/kg once daily for 5 days in combination with a reduction of immunosuppression, if possible (Ref).

Patients with HIV:

Note: Optimal dose not well-defined.

Initial: IV: 400 mg/kg once daily for 5 to 10 days or 1 g/kg once daily for 2 days (Ref).

Maintenance: Note: For patients with a CD4 count <100 cells/mm3 to prevent relapse (Ref).

IV: 400 mg/kg once every 4 weeks (Ref).

Pemphigus foliaceus and vulgaris, refractory

Pemphigus foliaceus and vulgaris, refractory (off-label use): IV: 2 g/kg administered in divided doses over 2 to 5 consecutive days (eg, 400 mg/kg once daily for 5 days); may repeat every 4 to 6 weeks based on clinical response (Ref).

Toxic shock syndrome, streptococcal

Toxic shock syndrome, streptococcal (adjunctive agent) (off-label use): IV: 1 g/kg on day 1, followed by 500 mg/kg once daily on days 2 and 3 (Ref).

Warm autoimmune hemolytic anemia

Warm autoimmune hemolytic anemia (adjunctive agent) (off-label use):

Note: May be used for patients who are improving but remain transfusion-dependent 2 weeks after starting first-line therapies (Ref).

IV: 500 mg/kg once daily for 4 days or 1 g/kg once daily for 2 days (Ref).

Switching from IV to SUBQ infusion dosing or switching between SUBQ products:

S witching from IV to SUBQ infusion dosing:

Cutaquig, Cuvitru:

SUBQ infusion: Begin treatment 1 week after patient's last IVIG dose.

Initial weekly dose (grams): Divide the previous IVIG dose (grams) by the number of weeks between IV doses, then multiply this dose by 1.3 (dose adjustment factor).

Every-2-week dosing (grams): Multiply the calculated weekly dose by 2.

Frequent (2 to 7 injections per week) dosing (grams): Divide the calculated weekly dose by the desired number of injections per week.

Note: For subsequent dose adjustments, refer to product labeling.

Gammagard Liquid, Gammaked, Gamunex-C:

SUBQ infusion: Begin 1 week after last IV dose. Use the following equation to calculate initial dose:

Initial weekly dose (grams) = [1.37 × previous IVIG dose (grams)] divided by [number of weeks between IV doses].

Note: For subsequent dose adjustments, refer to product labeling.

Hizentra:

SUBQ infusion: For weekly or frequent (up to daily) dosing, begin 1 week after last IVIG dose. For every-2-week dosing, begin 1 or 2 weeks after last IVIG dose. Note: Patient should have received IVIG routinely for at least 3 months before switching to SUBQ. Use the following equation to calculate initial weekly dose:

Initial weekly dose (grams) = [1.37 × previous IVIG dose (grams)] divided by [number of weeks between IV doses]. To convert the dose (in grams) to mL, multiply the calculated dose (in grams) by 5.

Note: Provided the total weekly dose is maintained, any dosing interval from daily up to every 2 weeks may be used. Use the following calculations to calculate frequent or every-2-week dosing:

Every-2-week dosing (grams): Multiply the calculated or previous weekly dose by 2.

Frequent (2 to 7 injections per week) dosing (grams): Divide the calculated or previous weekly dose by the desired number of injections per week.

Note: For subsequent dose adjustments, refer to product labeling.

HyQvia:

SUBQ infusion: For patients previously on another IVIG treatment, administer the first dose ~1 week after the last infusion of previous treatment.

Administer the same dose and frequency as the previous IVIG treatment after the initial dose ramp-up. For subsequent dose adjustments, refer to product labeling.

Xembify:

SUBQ infusion: Begin treatment 1 week after patient's last IVIG dose.

Initial weekly dose (grams): [1.37 × previous IVIG dose (grams)] divided by [number of weeks between IV doses].

Frequent (2 to 7 injections per week) dosing (grams): Divide the calculated weekly dose by the desired number of injections per week.

Note: For subsequent dose adjustments, refer to product labeling.

Switching between SUBQ products:

Cutaquig:

SUBQ infusion: Begin treatment 1 week after patient's last SUBQ immune globulin dose regardless of prior treatment regimen/frequency.

Initial weekly dose (grams): Use the same dose as the prior SUBQ immune globulin treatment (grams).

Every-2-week dosing (grams): Multiply the calculated weekly dose by 2.

Frequent (2 to 7 injections per week) dosing (grams): Divide the calculated weekly dose by the desired number of administration injections per week.

Note: For subsequent dose adjustments, refer to product labeling.

Cuvitru:

SUBQ infusion: Begin treatment 1 week after patient's last SUBQ immune globulin dose regardless of prior treatment regimen/frequency.

Weekly dosing (grams): Weekly dose is the same as the prior immune globulin SUBQ weekly dose. If switching from HyQvia, divide the previous HyQvia dose (grams) by the number of weeks between HyQvia doses, then multiply this dose by 1.3 (dose adjustment factor).

Every-2-week dosing (grams): Multiply the calculated weekly dose by 2.

Frequent (2 to 7 injections per week) dosing (grams): Divide the calculated weekly dose by the desired number of administration injections per week.

Note: For subsequent dose adjustments, refer to product labeling.

Hizentra:

SUBQ infusion: For weekly or frequent (up to daily) dosing, begin 1 week after last SUBQ infusion. For every-2-week dosing, begin 1 week after the last SUBQ weekly infusion. Note: Use the following equation to calculate initial weekly dose:

Initial weekly dose: Use previous weekly SUBQ dose initially.

Note: Provided the total weekly dose is maintained, any dosing interval from daily up to every 2 weeks may be used. Use the following conversions to calculate dosing:

Every-2-week dosing (grams): Multiply the calculated or previous weekly dose by 2.

Frequent (2 to 7 injections per week) dosing (grams): Divide the calculated or previous weekly dose by the desired number of injections per week.

Note: For subsequent dose adjustments, refer to product labeling.

HyQvia:

SUBQ infusion: Begin treatment 1 week after patient's last infusion of their previous treatment regardless of prior treatment regimen/frequency.

See manufacturer's labeling for initial ramp-up schedule (initiating treatment with a full monthly dose has not been evaluated).

Xembify:

SUBQ infusion: Weekly dose is the same as the prior immune globulin SUBQ weekly dose (grams).

Note: For subsequent dose adjustments, refer to product labeling.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

IV: Use with caution due to risk of immune globulin-induced renal dysfunction; the rate of infusion and concentration of solution should be minimized. Discontinue if renal function deteriorates during treatment.

IM: There are no dosage adjustments provided in the manufacturer's labeling.

SUBQ infusion: There are no dosage adjustments provided in the manufacturer's labeling; consider lower, more frequent dosing.

Dosing: Hepatic Impairment: Adult

IM, IV, SUBQ infusion: There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Immune globulin (Intravenous, subcutaneous, and intramuscular): Pediatric drug information")

Note: Not all products are interchangeable with regards to route of administration; consult manufacturers' labeling for additional information. Product-specific dosing is provided where applicable; approval ages vary by product; see manufacturers' labeling. Some clinicians use ideal body weight or an adjusted ideal body weight in morbidly obese patients to calculate an IVIG dose (Ref). Dosage expressed as mg/kg or mL/kg and is dependent upon route of administration; use extra caution to ensure accuracy.

Acute disseminated encephalomyelitis

Acute disseminated encephalomyelitis (ADEM): Limited data available: Children and Adolescents: IV: 1,000 mg/kg/dose once daily for 2 days (Ref).

Colitis due to Clostridioides difficile, chronic

Colitis due to Clostridioidesdifficile, chronic: Limited data available: Infants and Children: IV: 400 mg/kg/dose every 3 weeks resulted in resolution of colitis symptoms during treatment; duration of therapy was unclear (n=5; age range: 6 to 37 months) (Ref).

Dermatomyositis, refractory

Dermatomyositis, refractory: Limited data available: Children: IV: 1,000 mg/kg/dose once daily for 2 days; Note: If maintenance therapy is required, the dose and frequency should be based on clinical response and doses should not exceed 2,000 mg/kg per treatment course (Ref).

Guillain-Barré syndrome

Guillain-Barré syndrome: Limited data available: Various regimens have been used:

Children: IV: 1,000 mg/kg/dose once daily for 2 days (Ref) or 400 mg/kg/dose once daily for 5 days (Ref).

Hematopoietic cell transplantation with hypogammaglobulinemia, prevention of bacterial infection

Hematopoietic cell transplantation (HCT) with hypogammaglobulinemia (IgG <400 mg/dL), prevention of bacterial infection: Limited data available (Ref): Note: Increase dose or frequency to maintain IgG concentration >400 mg/dL.

Within first 100 days after HCT:

Infants and Children (Allogeneic HCT recipients): IV: 400 mg/kg/dose once monthly.

Adolescents: IV: 500 mg/kg/dose once weekly.

>100 days after HCT: Infants, Children, and Adolescents: IV: 500 mg/kg/dose every 3 to 4 weeks.

Hepatitis A, prophylaxis

Hepatitis A, prophylaxis: Limited data available:

Preexposure prophylaxis upon travel into endemic areas (Ref): Note: Hepatitis A vaccine preferred for pediatric patients ≥6 months (Ref):

Infants, Children, and Adolescents: GamaSTAN:

Anticipated duration of risk ≤1 month: IM: 0.1 mL/kg/dose as a single dose.

Anticipated duration of risk 1 to 2 months: IM: 0.2 mL/kg/dose as a single dose.

Anticipated duration of risk ≥2 months: IM: 0.2 mL/kg/dose every 2 months.

Postexposure prophylaxis (Ref): Note: Hepatitis A vaccine preferred for pediatric patients ≥12 months (Ref):

Infants: GamaSTAN: IM: 0.1 mL/kg/dose as a single dose given within 14 days of exposure and prior to manifestation of disease.

Children and Adolescents: GamaSTAN: IM: 0.1 mL/kg/dose as a single dose given within 14 days of exposure and prior to manifestation of disease; not needed if at least 1 dose of hepatitis A vaccine was given previously or as part of postexposure prophylaxis unless patient has chronic liver disease or is immunocompromised.

Bacterial infection prophylaxis in patients with HIV and hypogammaglobulinemia

Bacterial infection prophylaxis in patients with HIV and hypogammaglobulinemia: Limited data available (Ref):

Infants and Children:

Primary prophylaxis for serious bacterial infection in patients with hypogammaglobulinemia (IgG <400 mg/dL): IV: 400 mg/kg/dose every 2 to 4 weeks.

Secondary prophylaxis for invasive bacterial infections: Should only be used if subsequent infections are frequent severe infections (>2 infections during a 1-year period): IV: 400 mg/kg/dose every 2 to 4 weeks.

Immune thrombocytopenia

Immune thrombocytopenia (ITP):

Carimune NF 6%: Infants, Children, and Adolescents:

Acute therapy: IV: 400 mg/kg/dose once daily for 2 to 5 days to maintain platelet count ≥30,000/mm3 and/or to control significant bleeding. If platelet response is adequate (30,000 to 50,000/mm3) after the first 2 doses, then may discontinue therapy.

Chronic therapy: IV: 400 mg/kg/dose as a single infusion to maintain platelet count ≥30,000/mm3 and/or to control significant bleeding; may increase to 800 to 1,000 mg/kg/dose if response inadequate.

Flebogamma DIF 10%: Children ≥2 years and Adolescents: Chronic therapy: IV: 1,000 mg/kg/dose once daily for 2 consecutive days.

Gammaked, Gamunex-C: Infants, Children, and Adolescents: Acute or chronic therapy: IV: 400 mg/kg/dose once daily for 5 consecutive days or 1,000 mg/kg/dose once daily for 2 consecutive days; if an adequate platelet response is observed after the initial 1,000 mg/kg/dose, then the subsequent dose may be held.

Privigen: Adolescents ≥15 years: Chronic therapy: IV: 1,000 mg/kg/dose once daily for 2 days.

Kawasaki disease, treatment

Kawasaki disease, treatment: Limited data available: Note: Use in combination with aspirin; may consider the addition of corticosteroids in patients at high risk for IVIG resistance or developing coronary artery aneurysms (Ref).

Infants and Children: IV: 2,000 mg/kg as a single dose infused over 8 to 12 hours; usually administered within 10 days of disease onset; however, may be administered >10 days from onset in patients with delayed diagnosis or with persistent symptoms of systemic inflammation with persistent fever and/or coronary artery aneurysms. If signs and symptoms persist ≥36 hours after completion of the infusion, retreatment with a second dose of 1,000 or 2,000 mg/kg infusion may be considered with or without corticosteroids; a lower second dose has been suggested to minimize risk for adverse drug reactions (eg, hemolytic anemia) (Ref). Note: A maximum dose has not been defined; a reasonable maximum dose of 100 to 140 g/dose has been suggested during times of drug shortages or when cost is a consideration (Ref).

Measles, prophylaxis

Measles, prophylaxis: Note: Route of administration varies with product; verify route prior to administration.

ACIP recommendations (Ref): Infants, Children, and Adolescents:

Preexposure prophylaxis (eg, during an outbreak, travel to endemic area): Note: Indicated for patients already receiving immune globulin therapy.

IV: ≥400 mg/kg/dose within 3 weeks before anticipated exposure.

SUBQ: 200 mg/kg/dose once weekly for 2 consecutive weeks prior to anticipated exposure. Note: Not all immune globulin preparations may be administered by the SUBQ route; consult product labeling for additional information as market availability may change.

Postexposure prophylaxis (in any person without evidence of measles immunity):

Infants, Children, and Adolescents:

IM: 0.5 mL/kg/dose (maximum dose: 15 mL/dose) within 6 days of exposure; in adults, doses >10 mL should be split into multiple injections and administered at different sites; in pediatric patients, may also split doses <10 mL based on patient size. Note: Not all immune globulin preparations may be administered by the IM route; of the products currently available on the market, GamaSTAN may be given IM; consult product labeling for additional information as market availability may change. GamaSTAN manufacturer labeling suggests a lower IM dose; however, this dosing was based on previous immune globulin donor potency concentrations; recent data indicates that potency from current donor populations has decreased (ie, measles immunity now from vaccinations instead of immunity from disease) requiring a higher IM immune globulin dose (0.5 mL/kg) in all patients without evidence of measles immunity to ensure adequate serum titers.

IV: 400 mg/kg/dose within 6 days of exposure.

Product-specific dosing:

Cutaquig: SUBQ infusion: Patients with primary humoral immunodeficiency: Children ≥2 years and Adolescents:

Preexposure prophylaxis: SUBQ: Increase dose to ≥245 mg/kg/dose once weekly or equivalent if dosing is not on a weekly schedule (if current dose is less).

Cuvitru: SUBQ infusion: Patients with primary humoral immunodeficiency: Children ≥2 years and Adolescents:

Preexposure prophylaxis: SUBQ: Increase dose to ≥230 mg/kg/dose once weekly or equivalent if dosing is not on a weekly schedule (if current dose is less).

Flebogamma DIF 5%, Gammagard Liquid, Gammagard S/D, Gammaplex 5% and 10%: IV: Patients with primary humoral immunodeficiency: Children ≥2 years and Adolescents:

Preexposure prophylaxis: IV: Increase dose to ≥530 mg/kg every 3 to 4 weeks (if current dose is less).

Postexposure prophylaxis: IV: 400 mg/kg once as soon as possible and within 6 days of exposure.

GamaSTAN: IM: Infants, Children, and Adolescents

Immunocompromised:

Postexposure prophylaxis: IM: 0.5 mL/kg immediately; maximum dose: 15 mL/dose.

Immunocompetent:

Postexposure prophylaxis: IM: 0.25 mL/kg within 6 days of exposure. Note: CDC/ACIP recommend 0.5 mL/kg/dose for all patients (Ref).

Gammaked, Gamunex-C: IV: Children ≥2 years and Adolescents:

Preexposure prophylaxis: IV: Increase dose to ≥400 mg/kg every 3 to 4 weeks just prior to expected exposure (if current dose is less).

Postexposure prophylaxis: IV: 400 mg/kg once as soon as possible after exposure.

Hizentra: SUBQ infusion: Patients with primary humoral immunodeficiency: Children ≥2 years and Adolescents:

Preexposure prophylaxis: SUBQ:

Patients receiving weekly or more frequent dosing receiving <200 mg/kg weekly: Increase dose to ≥200 mg/kg/dose weekly for 2 consecutive weeks.

Patients receiving biweekly dosing: Increase dose to ≥400 mg/kg once (if current dose is less).

Postexposure prophylaxis (regardless of prior dosing schedule): SUBQ: 400 mg/kg administered as soon as possible after exposure.

Octagam 5%: IV: Patients with primary humoral immunodeficiency: Children ≥6 years and Adolescents:

Preexposure prophylaxis: IV: Increase dose to ≥530 mg/kg every 3 to 4 weeks (if current dose is less).

Postexposure prophylaxis: IV: 400 mg/kg once as soon as possible and within 6 days of exposure.

Privigen: IV: Patients with primary humoral immunodeficiency: Children ≥3 years and Adolescents:

Preexposure prophylaxis: IV: Increase dose to ≥530 mg/kg every 3 to 4 weeks (if current dose is less).

Postexposure prophylaxis: IV: 400 mg/kg once as soon as possible and within 6 days of exposure.

Multiple sclerosis

Multiple sclerosis (relapsing-remitting, when other therapies cannot be used): Limited data available:

Children and Adolescents: Dosage regimen variable; optimal dose not established: IV: 1,000 mg/kg/dose once monthly, with or without an induction of 400 mg/kg/day for 5 days (Ref).

Multisystem inflammatory syndrome in children associated with SARS-CoV-2

Multisystem inflammatory syndrome in children (MIS-C) associated with SARS-CoV-2: Limited data available:

Note: Recommended for initial therapy in combination with glucocorticoids (ie, methylprednisolone) (Ref).

Infants, Children, and Adolescents: IV: 2,000 mg/kg once, infused over ~12 hours; maximum dose: 100 g (Ref). Note: If cardiac function is impaired or patient is fluid overloaded, consider slowing administration rate (eg, ≥16 hours) or splitting into 2 infusions (1,000 mg/kg/dose daily for 2 days); monitor fluid status closely (Ref).

Myasthenia gravis, severe exacerbation

Myasthenia gravis, severe exacerbation: Limited data available: Children: IV: 400 to 1,000 mg/kg/dose once daily over 2 to 5 days for a total dose of 2,000 mg/kg; if additional therapy required, dose should be based on clinical response and titrated to minimum effective dose (Ref).

Myocarditis, acute

Myocarditis, acute: Limited data available: Infants, Children, and Adolescents: IV: 2,000 mg/kg as a single dose. A cohort study of 21 children showed improvement in LVF recovery and survival at 1 year as compared to untreated historical cohort (Ref); efficacy results are variable (Ref); the largest data analysis did not show clear clinical benefit nor positive impact on survival (Ref).

Primary immunodeficiency disorders

Primary immunodeficiency disorders: Adjust dose/frequency based on desired IgG concentration and clinical response; a trough IgG concentration of ≥500 mg/dL has been recommended by some experts (Ref); consult product specific labeling for appropriate age groups.

IV infusion:

Asceniv: Children ≥12 years and Adolescents: IV: 300 to 800 mg/kg every 3 to 4 weeks.

Bivigam: Children ≥6 years and Adolescents: IV: 300 to 800 mg/kg every 3 to 4 weeks.

Carimune NF: Infants, Children, and Adolescents: IV: 400 to 800 mg/kg/dose every 3 to 4 weeks.

Flebogamma 5% DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gamunex-C, Panzyga: Children ≥2 years and Adolescents: IV: 300 to 600 mg/kg/dose every 3 to 4 weeks.

Gammaplex 5% and 10%: Children ≥2 years and Adolescents: IV: 300 to 800 mg/kg every 3 to 4 weeks.

Octagam 5%: Children ≥6 years and Adolescents: IV: 300 to 600 mg/kg/dose every 3 to 4 weeks.

Privigen: Children ≥3 years and Adolescents: IV: 200 to 800 mg/kg/dose every 3 to 4 weeks.

SUBQ infusion:

Cutaquig, Cuvitru: Children ≥2 years and Adolescents:

Patients switching from IGIV therapy: SUBQ infusion: Begin 1 week after last immune globulin IV dose. Use the following equations to calculate initial dose:

Initial weekly dosing: Dose (grams) = (IV dose [grams] divided by IV dose interval [weeks]), then multiply this dose by 1.3 (dose adjustment factor). Note: To convert the dose (in grams) to mL, multiply the calculated dose (in grams) by 5 (for Cuvitru) or by 6 (for Cutaquig).

Biweekly dosing (grams): Multiply the calculated weekly dose by 2.

Frequent dosing (2 to 7 times per week) (grams): Divide the calculated weekly dose by the desired number of times per week.

Note: For subsequent dose adjustments, refer to product labeling.

Patients switching from another IG SubQ product: SUBQ infusion:

Weekly dosing (grams): Weekly dose is the same as the prior immune globulin subcutaneous weekly dose.

Biweekly dosing (grams): Multiply the calculated weekly dose by 2.

Frequent dosing (2 to 7 times per week) (grams): Divide the calculated weekly dose by the desired number of administration times per week.

Note: For subsequent dose adjustments, refer to product labeling.

Gammagard Liquid, Gammaked, Gamunex-C: Children ≥2 years and Adolescents: SUBQ infusion: Begin 1 week after last IV dose. Use the following equation to calculate initial dose:

Initial weekly dose: Dose (grams) = (1.37 x IV dose [grams]) divided by (IV dose interval [weeks]); Note: For subsequent doses, refer to product labeling. Note: To convert the dose (in grams) to mL, multiply the calculated dose (in grams) by 10.

Hizentra: Children ≥2 years and Adolescents: SUBQ infusion: For weekly dosing or frequent (up to daily), begin 1 week after last IV or SUBQ infusion. For biweekly dosing, begin 1 or 2 weeks after last IV infusion or 1 week after the last SUBQ weekly infusion. Note: Patient should have received an IV immune globulin routinely for at least 3 months before switching to SUBQ. Use the following equation to calculate initial dose:

Initial weekly dose: Dose (grams) = (Previous IV dose [grams]) divided by (IV dose interval [weeks]) then multiply by 1.37; if switching from a different SUBQ formulation to Hizentra, maintain previous weekly SUBQ dose initially. Note: To convert the dose (in grams) to mL, multiply the calculated dose (in grams) by 5.

Note: Provided the total weekly dose is maintained, any dosing interval from daily up to biweekly (every 2 weeks) may be used. Use the following calculations to calculate frequent or biweekly dosing:

Biweekly dose (grams): Dose = Calculated or previous weekly SUBQ dose (grams) multiplied by 2.

Frequent (2 to 7 times per week) dosing: Dose (grams) = Calculated or previous weekly dose (grams) divided by the desired number of times per week (eg, for 3 times per week dosing, divide weekly dose by 3).

Note: For subsequent doses refer to product labeling.

Xembify: Children ≥2 years and Adolescents:

Patients switching from another IG SUBQ product: SUBQ infusion: Weekly dose is the same as the prior immune globulin subcutaneous weekly dose (grams).

Note: For subsequent dose adjustments, refer to product labeling.

Patients switching from IGIV therapy: SUBQ infusion: Begin treatment 1 week after patient's last immune globulin IV.

Initial weekly dosing (grams): Previous IV dose (grams) divided by IV dose interval (weeks) then multiply by 1.37. Note: To convert the dose (in grams) to mL, multiply the calculated dose (in grams) by 5.

Note: For subsequent dose adjustments, refer to product labeling.

Frequent (2 to 7 times per week) dosing (grams): Divide the calculated weekly dose by the desired number of times per week.

Rubella, prophylaxis during pregnancy

Rubella, prophylaxis during pregnancy (postexposure): GamaSTAN: Adolescents: IM: 0.55 mL/kg/dose as a single dose within 72 hours of exposure (Ref); Note: Not recommended for routine use; may reduce, but not eliminate, risk for rubella. In adults, total dose volumes >10 mL should be split into multiple injections given at different sites.

Stevens-Johnson syndrome/toxic epidermal necrolysis

Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN): Limited data available:

Infants, Children, and Adolescents: IV: Usual dose: 1,500 to 2,000 mg/kg total dose as a single dose or divided over 2 to 4 days; dosing based on retrospective reviews and case reports; efficacy results are variable (Ref).

Varicella-zoster, postexposure prophylaxis

Varicella-zoster, postexposure prophylaxis (independent of HIV-status):

Infants, Children, and Adolescents: Note: Use only if varicella-zoster immune globulin is unavailable.

IV: 400 mg/kg as a single infusion as soon as possible and within 10 days of exposure; ideally within 96 hours of exposure (Ref).

IM: GamaSTAN: 0.6 to 1.2 mL/kg/dose as a single dose within 72 hours of exposure (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

IV: Use with caution due to risk of immune globulin-induced renal dysfunction; the rate of infusion and concentration of solution should be minimized. Discontinue if renal function deteriorates during treatment.

IM: There are no dosage adjustments provided in the manufacturer's labeling.

SubQ infusion: There are no dosage adjustments provided in the manufacturer's labeling; consider lower, more frequent dosing.

Dosing: Hepatic Impairment: Pediatric

IM, IV, SubQ infusion: There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing. Use with caution; administer the minimum dose and infusion rate practicable.

Dosing: Obesity: Adult

The recommendations for dosing in patients with obesity are based upon the best available evidence and clinical expertise. Senior Editorial Team: Jeffrey F. Barletta, PharmD, FCCM; Manjunath P. Pai, PharmD, FCP; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC.

Class 1, 2, and 3 obesity (BMI ≥30 kg/m2): IV, SUBQ: Use adjusted body weight for weight-based dose calculations (Ref). Refer to adult dosing for indication-specific doses.

Rationale for recommendations: The volume of distribution for IV immune globulin mimics plasma volume, which scales nonlinearly with body weight (Ref). Likewise, the clearance of IV immune globulin is regulated by intracellular uptake and lysosomal degradation that are nonlinear processes relative to weight and may be upregulated in patients with obesity in active inflammatory states (Ref). These factors contribute to the high interindividual pharmacokinetic and pharmacodynamic variability of this biologic class for both IV and SUBQ administration (Ref). The pharmacokinetic profile supports dose capping for body weight or use of an alternate weight descriptor for dosing in obesity. Consequently, a discordance exists in IV immune globulin dosing based on body weight across institutions (Ref). Given the cost and institutional resource considerations, use of ideal body weight and adjusted body weight strategies have been compared retrospectively (Ref). While generally underpowered, these studies do not suggest a higher risk for failure with the use of these alternate weight descriptors. Therefore, use adjusted body weight for weight-based dose calculations in patients with BMI ≥30 kg/m2 to enable similar immune globulin trough concentrations compared to patients with BMI <30 kg/m2 when dosed on actual body weight (Ref).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Injectable, Intramuscular [preservative free]:

GamaSTAN: 15% to 18% [150 to 180 mg/mL] (2 mL, 10 mL)

Kit, Subcutaneous:

Hyqvia: 10 g immune globulin (human)/100 mL with an 800 unit hyaluronidase vial, 5 g immune globulin (human)/50 mL with a 400 unit hyaluronidase vial, 2.5 g immune globulin (human)/25 mL with a 200 unit hyaluronidase vial, 20 g immune globulin (human)/200 mL with a 1,600 unit hyaluronidase vial, 30 g immune globulin (human)/300 mL with a 2,400 unit hyaluronidase vial [contains albumin human, edetate (edta) disodium dihydrate]

Solution, Injection [preservative free]:

Gammagard: 1 g/10 mL (10 mL); 2.5 g/25 mL (25 mL); 5 g/50 mL (50 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL); 30 g/300 mL (300 mL) [latex free]

Gammaked: 1 g/10 mL (10 mL); 5 g/50 mL (50 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL) [latex free]

Gamunex-C: 1 g/10 mL (10 mL); 2.5 g/25 mL (25 mL); 5 g/50 mL (50 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL); 40 g/400 mL (400 mL) [latex free]

Solution, Intravenous [preservative free]:

Asceniv: 5 g/50 mL (50 mL) [contains polysorbate 80]

Bivigam: 10 g/100 mL (100 mL) [latex free, sugar free; contains polysorbate 80]

Bivigam: 5 g/50 mL (50 mL) [contains polysorbate 80]

Bivigam: 5 g/50 mL (50 mL [DSC]) [sugar free; contains polysorbate 80]

Flebogamma DIF: 0.5 g/10 mL (10 mL); 5 g/50 mL (50 mL); 5 g/100 mL (100 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL); 20 g/400 mL (400 mL); 10 g/200 mL (200 mL); 2.5 g/50 mL (50 mL) [contains polyethylene glycol (macrogol)]

Gammaplex: 5 g/50 mL (50 mL); 5 g/100 mL (100 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL); 20 g/400 mL (400 mL); 10 g/200 mL (200 mL) [contains polysorbate 80]

Octagam: 1 g/20 mL (20 mL); 2 g/20 mL (20 mL); 5 g/50 mL (50 mL); 5 g/100 mL (100 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL); 25 g/500 mL (500 mL [DSC]); 30 g/300 mL (300 mL); 10 g/200 mL (200 mL); 2.5 g/50 mL (50 mL) [sucrose free]

Panzyga: Immune globulin (human)-ifas 1 g/10mL (10 mL); Immune globulin (human)-ifas 30 g/300 mL (300 mL); Immune globulin (human)-ifas 20 g/200 mL (200 mL); Immune globulin (human)-ifas 2.5 g/25 mL (25 mL); Immune globulin (human)-ifas 10 g/100 mL (100 mL); Immune globulin (human)-ifas 5 g/50 mL (50 mL) [latex free]

Panzyga: Immune globulin (human)-ifas 1 g/10mL (10 mL); Immune globulin (human)-ifas 5 g/50 mL (50 mL); Immune globulin (human)-ifas 10 g/100 mL (100 mL); Immune globulin (human)-ifas 2.5 g/25 mL (25 mL); Immune globulin (human)-ifas 20 g/200 mL (200 mL); Immune globulin (human)-ifas 30 g/300 mL (300 mL)

Privigen: 5 g/50 mL (50 mL); 10 g/100 mL (100 mL); 20 g/200 mL (200 mL); 40 g/400 mL (400 mL)

Solution, Subcutaneous [preservative free]:

Cutaquig: 1 g/6 mL (6 mL); 1.65 g/10 mL (10 mL); 2 g/12 mL (12 mL); 3.3 g/20 mL (20 mL); 4 g/24 mL (24 mL); 8 g/48 mL (48 mL) [latex free; contains polysorbate 80]

Cuvitru: 1 g/5 mL (5 mL); 2 g/10 mL (10 mL); 4 g/20 mL (20 mL); 8 g/40 mL (40 mL); 10 g/50 mL (50 mL)

Hizentra: 1 g/5 mL (5 mL); 2 g/10 mL (10 mL); 4 g/20 mL (20 mL); 10 g/50 mL (50 mL) [contains polysorbate 80]

Xembify: Immune globulin (human)-klhw 1 g/5 mL (5 mL); Immune globulin (human)-klhw 2 g/10 mL (10 mL); Immune globulin (human)-klhw 4 g/20 mL (20 mL); Immune globulin (human)-klhw 10 g/50 mL (50 mL) [latex free; contains polysorbate 80]

Solution Prefilled Syringe, Subcutaneous:

Hizentra: 1 g/5 mL (5 mL); 2 g/10 mL (10 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Hizentra: 4 g/20 mL (20 mL) [contains polysorbate 80]

Solution Reconstituted, Intravenous [preservative free]:

Carimune NF: 6 g (1 ea [DSC]); 12 g (1 ea [DSC])

Gammagard S/D Less IgA: 5 g (1 ea); 10 g (1 ea) [contains albumin human, polyethylene glycol (macrogol), polysorbate 80]

Generic Equivalent Available: US

No

Dosage Forms Considerations

Carimune NF may contain a significant amount of sodium and also contains sucrose.

Cutaquig contains maltose.

Gammagard S/D may contain a significant amount of sodium and also contains glucose.

Octagam contains maltose.

Hyqvia Kit is supplied with a Hyaluronidase (Human Recombinant) component intended for injection prior to Immune Globulin administration to improve dispersion and absorption of the Immune Globulin.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Injectable, Intramuscular:

Gamastan S/D: 15% to 18% [150 to 180 mg/mL] ([DSC])

Solution, Intravenous:

Gammagard: 10% (10 mL, 25 mL, 50 mL, 100 mL, 200 mL, 300 mL)

Gamunex: 10% (25 mL, 50 mL, 100 mL, 200 mL, 400 mL)

Octagam: 5% (50 mL, 100 mL, 200 mL); 10% (20 mL, 50 mL, 100 mL, 200 mL)

Panzyga: 100 mg/mL (10 mL, 25 mL, 50 mL, 100 mL, 200 mL, 300 mL)

Privigen: 10% (25 mL, 50 mL, 100 mL, 200 mL, 400 mL)

Solution, Subcutaneous:

Cutaquig: 165 mg/mL (6 mL, 12 mL, 24 mL, 48 mL) [contains polysorbate 80]

Hizentra: 200 mg/mL (5 mL, 10 mL, 15 mL, 20 mL) [contains polysorbate 80]

Generic: 200 mg/mL (5 mL, 10 mL, 20 mL, 40 mL, 50 mL)

Solution Prefilled Syringe, Subcutaneous:

Hizentra: 4 g/20 mL (20 mL) [contains polysorbate 80]

Solution Reconstituted, Intravenous:

Gammagard S/D: 5 g (1 ea); 10 g (1 ea) [contains albumin human, polyethylene glycol (macrogol), polysorbate 80]

IGIVnex: 10 g (10 mL, 25 mL, 50 mL, 100 mL, 200 mL)

Iveegam Immuno: 1 g (1 ea); 7.5 g (1 ea); 10 g (1 ea)

Administration: Adult

Note: If plasmapheresis employed for treatment of condition, administer immune globulin after completion of plasmapheresis session.

IM: Administer IM in the anterolateral aspects of the upper thigh or deltoid muscle of the upper arm. Avoid gluteal region due to risk of injury to sciatic nerve. Divide doses >10 mL and inject in multiple sites.

GamaSTAN and GamaSTAN S/D [Canadian product] are for IM administration only.

IV infusion: Infuse over 2 to 24 hours; administer in separate infusion line from other medications; if using primary line, flush with NS or D5W (product specific; consult product prescribing information) prior to administration. Decrease dose, rate and/or concentration of infusion in patients who may be at risk of renal failure. Decreasing the rate or stopping the infusion may help relieve some adverse effects (flushing, changes in pulse rate, changes in blood pressure). Epinephrine should be available during administration. For initial treatment or in elderly patients, a lower concentration and/or a slower rate of infusion should be used. Initial rate of administration and titration is specific to each IGIV product. Refrigerated product should be warmed to room temperature prior to infusion. Some products require filtration; refer to individual product labeling. Antecubital veins should be used, especially with concentrations ≥10% to prevent injection-site discomfort.

Asceniv: Primary humoral immunodeficiency: Initial (first 15 minutes): 0.5 mg/kg/minute (0.3 mL/kg/hour); Maintenance: Increase every 15 minutes (if tolerated) up to 8 mg/kg/minute (4.8 mL/kg/hour).

Bivigam 10%: Primary humoral immunodeficiency: Initial (first 10 minutes): 0.5 mg/kg/minute (0.3 mL/kg/hour); Maintenance: Increase every 20 minutes (if tolerated) by 0.8 mg/kg/minute (0.48 mL/kg/hour) up to 6 mg/kg/minute (3.6 mL/kg/hour).

Carimune NF: Refer to product labeling.

Flebogamma DIF 5%: Primary humoral immunodeficiency: Initial: 0.5 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Increase slowly (if tolerated) up to 5 mg/kg/minute (6 mL/kg/hour).

Flebogamma DIF 10%: Primary humoral immunodeficiency or immune thrombocytopenia: Initial: 1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Increase slowly (if tolerated) up to 8 mg/kg/minute (4.8 mL/kg/hour).

Gammagard Liquid 10%:

Multifocal motor neuropathy: Initial: 0.8 mg/kg/minute (0.5 mL/kg/hour); Maintenance: Increase gradually (if tolerated) up to 9 mg/kg/minute (5.4 mL/kg/hour).

Primary humoral immunodeficiency: Initial (first 30 minutes): 0.8 mg/kg/minute (0.5 mL/kg/hour); Maintenance: Increase every 30 minutes (if tolerated) up to: 8 mg/kg/minute (5 mL/kg/hour).

Gammagard S/D [Canadian product]: 5% solution: Initial: 0.5 mL/kg/hour; may increase (if tolerated) to a maximum rate of 4 mL/kg/hour. If 5% solution is tolerated at maximum rate, may administer 10% solution with an initial rate of 0.5 mL/kg/hour; may increase (if tolerated) to a maximum rate of 8 mL/kg/hour.

Gammaked 10%:

Chronic inflammatory demyelinating polyneuropathy (CIDP): Initial (first 30 minutes): 2 mg/kg/minute (1.2 mL/kg/hour); Maintenance: Increase gradually (if tolerated) to a maximum of 8 mg/kg/minute (4.8 mL/kg/hour).

Primary humoral immunodeficiency or immune thrombocytopenia (ITP): Initial (first 30 minutes): 1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Increase gradually (if tolerated) to a maximum of 8 mg/kg/minute (4.8 mL/kg/hour).

Gammaplex 5%: Primary humoral immunodeficiency or ITP: Initial (first 15 minutes): 0.5 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Increase every 15 minutes (if tolerated) up to 4 mg/kg/minute (4.8 mL/kg/hour).

Gammaplex 10%: Primary humoral immunodeficiency or ITP: Initial (first 15 minutes): 0.5 mg/kg/minute (0.3 mL/kg/hour); Maintenance: Increase every 15 minutes (if tolerated) up to 8 mg/kg/minute (4.8 mL/kg/hour).

Gamunex-C 10%:

CIDP: Initial (first 30 minutes): 2 mg/kg/minute (1.2 mL/kg/hour); Maintenance: Increase gradually (if tolerated) to a maximum of 8 mg/kg/minute (4.8 mL/kg/hour).

Primary humoral immunodeficiency or ITP: Initial (first 30 minutes): 1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Increase gradually (if tolerated) to a maximum of 8 mg/kg/minute (4.8 mL/kg/hour).

Octagam 5%: Primary humoral immunodeficiency: Initial (first 30 minutes): 0.5 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Double infusion rate (if tolerated) every 30 minutes up to a maximum rate of <3.33 mg/kg/minute (4.2 mL/kg/hour).

Octagam 10%: ITP: Initial (first 30 minutes):1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Double infusion rate (if tolerated) every 30 minutes up to a maximum rate of 12 mg/kg/minute (7.2 mL/kg/hour).

Panzyga:

CIDP: Initial (first 30 minutes): 1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: Increase gradually (if tolerated) every 15 to 30 minutes up to 12 mg/kg/minute (7.2 mL/kg/hour).

ITP: Initial (first 30 minutes): 1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: May increase gradually (if tolerated) every 15 to 30 minutes up to 8 mg/kg/minute (4.8 mL/kg/hour).

Primary humoral immunodeficiency: Initial (first 30 minutes): 1 mg/kg/minute (0.6 mL/kg/hour); Maintenance: May increase gradually (if tolerated) every 15 to 30 minutes up to 14 mg/kg/minute (8.4 mL/kg/hour).

Privigen 10%:

ITP: Initial: 0.5 mg/kg/minute (0.3 mL/kg/hour); Maintenance: Increase gradually (if tolerated) up to 4 mg/kg/minute (2.4 mL/kg/hour).

CIDP/Primary humoral immunodeficiency: Initial: 0.5 mg/kg/minute (0.3 mL/kg/hour); Maintenance: Increase gradually (if tolerated) up to 8 mg/kg/minute (4.8 mL/kg/hour).

SUBQ infusion: Initial dose should be administered in a health care setting capable of providing monitoring and treatment in the event of hypersensitivity. Using aseptic technique, follow the infusion device manufacturer's instructions for filling the reservoir and preparing the pump. Remove air from administration set and needle by priming. After the administration sites are clean and dry, insert subcutaneous needle and prime administration set. Attach sterile needle to administration set, gently pull back on the syringe to assure a blood vessel has not been inadvertently accessed (do not use needle and tubing if blood present). Repeat for each injection site; deliver the dose following instructions for the infusion device. Rotate the site(s) between successive infusions. Treatment may be transitioned to the home/home care setting in the absence of adverse reactions.

Cutaquig:

Injection sites: Abdomen, thigh, upper arm, and/or upper leg/hip; ≤6 simultaneous injection sites (spaced ≥2 inches apart).

Maximum infusion rate: 20 mL/hour per injection site (first 2 infusions); may be increased to 52 mL/hour per injection site (as tolerated) for subsequent infusions.

Maximum infusion volume: 25 mL per injection site (first 2 infusions); may increase to 40 mL per site for subsequent infusions.

Cuvitru: Note: Manufacturer recommends to complete administration within 2 hours due to the potential formation of particles caused by siliconized syringes.

Injection sites: Abdomen, thigh, upper arm, lateral hip (avoid bony prominences); ≤4 simultaneous injection sites (spaced ≥4 inches apart).

Maximum infusion rate: 10 to 20 mL/hour per injection site (first 2 infusions); may be increased to 60 mL/hour per injection site (as tolerated) for subsequent infusions.

Maximum infusion volume:

Patients <40 kg: 20 mL per injection site (first 2 infusions); may increase to 60 mL per site for subsequent infusions.

Patients ≥40 kg: 60 mL per injection site.

Gammagard Liquid:

Injection sites: Abdomen, thigh, upper arm, lower back (avoid bony prominences); ≤8 simultaneous injection sites (spaced ≥2 inches apart).

Initial infusion rate:

<40 kg: 15 mL/hour per injection site (maximum volume: 20 mL per injection site).

≥40 kg: 20 mL/hour per injection site (maximum volume: 30 mL per injection site).

Maintenance infusion rate:

<40 kg: 15 to 20 mL/hour per injection site (maximum volume: 20 mL per injection site).

≥40 kg: 20 to 30 mL/hour per injection site (maximum volume: 30 mL per injection site).

Gammaked, Gamunex-C:

Injection sites: Abdomen, thigh, upper arm, lateral hip; ≤8 simultaneous injection sites (spaced ≥2 inches apart).

Recommended infusion rate: 20 mL/hour per infusion site.

Hizentra:

Injection sites: Abdomen, thigh, upper arm, lateral hip; ≤8 simultaneous injection sites in parallel (spaced ≥2 inches apart).

Maximum infusion rate: First infusion: 15 mL/hour per injection site (primary humoral immunodeficiency) or 20 mL/hour per injection site (CIDP); subsequent infusions: 25 mL/hour per injection site (primary humoral immunodeficiency) or 50 mL/hour per injection site (CIDP).

Maximum infusion volume: First infusion: 15 mL per injection site (primary humoral immunodeficiency) or 20 mL per injection site (CIDP); subsequent infusions: 25 mL per injection site (primary humoral immunodeficiency) or 50 mL per injection site (CIDP).

HyQvia: Infuse the two components of HyQvia (immune globulin and hyaluronidase) sequentially, beginning with hyaluronidase; do not use either component alone. Infusion pump capable of infusing rates up to 300 mL/hour/site is required; must also have the ability to titrate the flow rate. Use a 24 gauge subcutaneous needle set labeled for high flow rates. Infusion site leakage can occur; consider using longer needles (14 mm or 12 mm) and/or more than one infusion site. Initiate the infusion of the full dose of the immune globulin through the same subcutaneous needle set within ~10 minutes of hyaluronidase infusion. For each full or partial vial of immune globulin used, administer the entire contents of the hyaluronidase vial. A second site can be used based on tolerability and total volume; if a second site is used, administer half of total volume of the hyaluronidase in each site. Flush the infusion line with NS or D5W if required.

Injection sites: Middle to upper abdomen or thigh (avoid bony prominences, or areas that are scarred, inflamed, or infected). If two sites are used simultaneously, the two infusion sites should be on opposite sides of the body.

Volume per site:

<40 kg: ≤300 mL per injection site.

≥40 kg: ≤600 mL per injection site.

Infusion rate:

Hyaluronidase: ~1 to 2 mL/minute, or as tolerated.

Immune globulin:

First 2 infusions:

<40 kg: 5 mL/hour for 5 to 15 minutes; 10 mL/hour for 5 to 15 minutes; 20 mL/hour for 5 to 15 minutes; 40 mL/hour for 5 to 15 minutes; then 80 mL/hour for remainder of infusion.

≥40 kg: 10 mL/hour for 5 to 15 minutes; 30 mL/hour for 5 to 15 minutes; 60 mL/hour for 5 to 15 minutes; 120 mL/hour for 5 to 15 minutes; then 240 mL/hour for remainder of infusion.

Next 2 or 3 infusions:

<40 kg: 10 mL/hour for 5 to 15 minutes; 20 mL/hour for 5 to 15 minutes; 40 mL/hour for 5 to 15 minutes; 80 mL/hour for 5 to 15 minutes; then 160 mL/hour for remainder of infusion.

≥40 kg: 10 mL/hour for 5 to 15 minutes; 30 mL/hour for 5 to 15 minutes; 120 mL/hour for 5 to 15 minutes; 240 mL/hour for 5 to 15 minutes; then 300 mL/hour for remainder of infusion.

Xembify: Note: Manufacturer recommends to complete administration within 2 hours due to the potential formation of particles caused by siliconized syringes.

Injection sites: Abdomen, thigh, upper arm, sides, back, lateral hip (avoid bony prominences or areas that are scarred, inflamed, or infected); ≤6 simultaneous injection sites (spaced ≥2 inches apart).

Maximum infusion rate: 25 mL/hour per injection site.

Maximum infusion volume: 25 mL per injection site.

Administration: Pediatric

Parenteral: Note: If plasmapheresis employed for treatment of condition, administer immune globulin after completion of plasmapheresis session.

IV: Infuse over 2 to 24 hours with initial infusion administered slowly and titrated as tolerated; administer in separate infusion line from other medications; if using primary line, flush with NS or D5W (product specific; consult product prescribing information) prior to administration. Decrease dose, rate, and/or concentration of infusion in patients who may be at risk of renal failure. Decreasing the rate or stopping the infusion may help relieve some adverse effects (flushing, changes in pulse rate, changes in blood pressure). Epinephrine should be available during administration.

For initial treatment, a lower concentration and/or a slower rate of infusion should be used. Initial rate of administration and titration is specific to each IVIG product. Refrigerated products should be warmed to room temperature prior to infusion. Some products require filtration; refer to individual product labeling. Antecubital veins should be used, especially with concentrations ≥10% to prevent injection site discomfort.

Asceniv 10%: Primary humoral immunodeficiency: Initial (first 15 minutes): 0.5 mg/kg/minute (0.3 mL/kg/hour); if tolerated, increase every 15 minutes up to 8 mg/kg/minute (4.8 mL/kg/hour).

Bivigam 10%: Primary humoral immunodeficiency: Initial rate: 0.5 mg/kg/minute (0.3 mL/kg/hour) for 10 minutes; if tolerated, increase every 20 minutes by 0.8 mg/kg/minute (0.48 mL/kg/hour) up to 6 mg/kg/minute (3.6 mL/kg/hour).

Carimune NF: Primary humoral immunodeficiency or immune thrombocytopenia: Initial rate: 0.5 mg/kg/minute for 30 minutes; if tolerated, increase to 1 mg/kg/minute, if tolerated after 30 minutes, may increase gradually up to 3 mg/kg/minute; rate in mL/kg/hour varies based on concentration; refer to product labeling.

Flebogamma DIF 5%: Primary humoral immunodeficiency: Initial rate: 0.5 mg/kg/minute (0.6 mL/kg/hour) for the first 30 minutes; if tolerated, increase slowly up to 5 mg/kg/minute (6 mL/kg/hour).

Flebogamma DIF 10%: Primary humoral immunodeficiency or immune thrombocytopenia: Initial rate: 1 mg/kg/minute (0.6 mL/kg/hour) for first 30 minutes; if tolerated, increase slowly up to 8 mg/kg/minute (4.8 mL/kg/hour).

Gammagard Liquid 10%: Primary humoral immunodeficiency: Initial rate: 0.8 mg/kg/minute (0.5 mL/kg/hour) for 30 minutes; if tolerated, increase every 30 minutes up to 8 mg/kg/minute (5 mL/kg/hour).

Gammagard S/D: 5% solution: Initial rate: 0.5 mL/kg/hour; if tolerated, may increase to a maximum rate of 4 mL/kg/hour. If 5% solution is tolerated at maximum rate, may administer 10% solution with an initial rate of 0.5 mL/kg/hour; if tolerated, may increase to a maximum rate of 8 mL/kg/hour.

Gammaked 10%:

CIDP: Initial rate: 2 mg/kg/minute (1.2 mL/kg/hour) for 30 minutes; if tolerated, increase gradually up to 8 mg/kg/minute (4.8 mL/kg/hour).

Primary humoral immunodeficiency or ITP: Initial rate: 1 mg/kg/minute (0.6 mL/kg/hour) for 30 minutes; if tolerated, increase gradually up to 8 mg/kg/minute (4.8 mL/kg/hour).

Gammaplex 5%: Primary humoral immunodeficiency or ITP: Initial rate: 0.5 mg/kg/minute (0.6 mL/kg/hour) for 15 minutes; if tolerated, increase every 15 minutes up to 4 mg/kg/minute (4.8 mL/kg/hour).

Gammaplex 10%: Primary humoral immunodeficiency or ITP: Initial rate: 0.5 mg/kg/minute (0.3 mL/kg/hour) for 15 minutes; if tolerated, increase every 15 minutes up to 8 mg/kg/minute (4.8 mL/kg/hour).

Gamunex-C 10%:

CIDP: Initial rate: 2 mg/kg/minute (1.2 mL/kg/hour) for 30 minutes; if tolerated, increase gradually up to 8 mg/kg/minute (4.8 mL/kg/hour).

Primary humoral immunodeficiency or ITP: Initial rate: 1 mg/kg/minute (0.6 mL/kg/hour) for 30 minutes; if tolerated, increase gradually up to 8 mg/kg/minute (4.8 mL/kg/hour).

Octagam 5%: Primary humoral immunodeficiency: Initial rate: 0.5 mg/kg/minute (0.6 mL/kg/hour) for 30 minutes; if tolerated, double the infusion rate every 30 minutes up to a maximum rate of <3.33 mg/kg/minute (4.2 mL/kg/hour).

Panzyga 10%: Primary humoral immunodeficiency: Initial (first 30 minutes): 1 mg/kg/minute (0.6 mL/kg/hour); if tolerated, increase gradually every 15 to 30 minutes up to 8 mg/kg/minute (4.8 mL/kg/hour) in treatment-naive patients or if it has been >8 weeks since last infusion or up to 12 to 14 mg/kg/minute (7.2 to 8.4 mL/kg/hour) in treatment-experienced patients.

Privigen 10%:

ITP: Initial rate: 0.5 mg/kg/minute (0.3 mL/kg/hour); if tolerated, increase gradually up to 4 mg/kg/minute (2.4 mL/kg/hour).

Primary humoral immunodeficiency: Initial rate: 0.5 mg/kg/minute (0.3 mL/kg/hour); if tolerated, increase gradually up to 8 mg/kg/minute (4.8 mL/kg/hour).

CIDP: Initial rate: 0.5 mg/kg/minute (0.3 mL/kg/hour); if tolerated, increase gradually up to 8 mg/kg/minute (4.8 mL/kg/hour).

IM: Administer IM in the anterolateral aspects of the upper thigh or deltoid muscle of the upper arm. Avoid gluteal region due to risk of injury to sciatic nerve. Divide doses >10 mL (adult) and inject in multiple sites; in pediatric patients, consider splitting doses <10 mL based on patient size.

SUBQ infusion: Initial dose should be administered in a health care setting capable of providing monitoring and treatment in the event of hypersensitivity. Using aseptic technique, follow the infusion device manufacturer's instructions for filling the reservoir and preparing the pump. Remove air from administration set and needle by priming. Dose may be infused into multiple sites simultaneously. After administration sites are clean and dry, insert subcutaneous needle and prime administration set. Attach sterile needle to administration set, gently pull back on the syringe to assure a blood vessel has not been inadvertently accessed; if blood is present, remove and discard needle and tubing; repeat process using a new needle and tubing and different injection site. Repeat for each injection site; deliver the dose following instructions for the infusion device. Rotate the site(s) between successive infusions. Treatment may be transitioned to the home/home care setting in the absence of adverse reactions.

Cutaquig:

Injection sites: Abdomen, thigh, upper arm, and/or upper leg/hip area (avoid areas that are scarred, tattooed, injured, or inflamed); ≤6 simultaneous injection sites (spaced ≥2 inches apart).

Recommended infusion rate:

Children ≥2 years and Adolescents <18 years: First 2 infusions: ≤15 mL/hour per injection site; subsequent infusions: Gradually increase as tolerated by ~5 to 10 mL/hour per injection site every 2 to 4 weeks to maximum rate of 25 mL/hour per injection site.

Adolescents ≥18 years: First 2 infusions: ≤20 mL/hour per injection site; subsequent infusions: Gradually increase as tolerated by ~10 mL/hour per injection site every 2 to 4 weeks to a maximum rate of 52 mL/hour per injection site.

Recommended infusion volume:

Children ≥2 to 6 years: First 2 infusions: ≤10 mL per injection site; subsequent infusions: Gradually increase as tolerated by ~5 to 10 mL per infusion site every 2 to 4 weeks up to a maximum of 15.5 mL per injection site.

Children >6 years and Adolescents <17 years: First 2 infusions: ≤15 mL per injection site; subsequent infusions: Gradually increase as tolerated by ~5 to 10 mL per infusion site every 2 to 4 weeks up to a maximum of 29 mL per injection site.

Adolescents ≥17 years: First 2 infusions: ≤25 mL per injection site; subsequent infusions: Gradually increase as tolerated by ~10 mL per infusion site every 2 to 4 weeks up to a maximum of 40 mL per site.

Cuvitru: Note: It is recommended that infusion be complete within 2 hours of preparation.

Injection sites: Abdomen, thighs, upper arms, or lateral hip (avoid bony areas, visible blood vessels, and areas that are scarred, inflamed, or infected); ≤4 simultaneous injection sites (spaced 4 inches apart or more).

Maximum infusion rate: 10 to 20 mL/hour per injection site (first 2 infusions); may be increased to 60 mL/hour per injection site (as tolerated) for subsequent infusions.

Maximum infusion volume:

Patients <40 kg: 20 mL per injection site (first 2 infusions); may increase to 60 mL per site for subsequent infusions.

Patients ≥40 kg: 60 mL per injection site.

Gammagard Liquid:

Injection sites: Abdomen, thighs, upper arms, or lower back (avoid bony areas, visible blood vessels, and areas that are scarred, inflamed, or infected); ≤8 simultaneous injection sites (spaced ≥2 inches apart).

Recommended infusion rate:

<40 kg: Initial infusion: 15 mL/hour per injection site; subsequent infusions: 15 to 20 mL/hour per injection site; maximum: 160 mL/hour for all simultaneous sites combined.

≥40 kg: Initial infusion: 20 mL/hour per injection site; subsequent infusions: 20 to 30 mL/hour per injection site; maximum: 240 mL/hour for all simultaneous sites combined.

Maximum infusion volume:

<40 kg: 20 mL per injection site.

≥40 kg: 30 mL per injection site.

Gammaked, Gamunex-C:

Injection sites: Abdomen, thighs, upper arms, and/or lateral hip; ≤6 simultaneous injection sites (spaced ≥2 inches apart) (≤8 sites may be used in adults).

Recommended infusion rate:

<25 kg: 10 mL/hour per infusion site.

≥25 kg: Initial: 15 mL/hour per infusion site; may increase up to 20 mL/hour per infusion site.

Hizentra:

Injection sites: Abdomen, thigh, upper arm, and/or lateral hip (avoid scars, stretch marks, and areas that are tender, bruised, red, or hard); ≤8 simultaneous injection sites (spaced ≥2 inches apart).

Maximum infusion rate: First infusion: 15 mL/hour per injection site (primary humoral immunodeficiency) or 20 mL/hour per injection site (CIDP); subsequent infusions: 25 mL/hour per injection site (primary humoral immunodeficiency) or 50 mL/hour per injection site (CIDP).

Maximum infusion volume: First infusions: 15 mL per injection site (primary humoral immunodeficiency) or 20 mL per injection site (CIDP); subsequent infusions: 25 mL per injection site (primary humoral immunodeficiency) or 50 mL per injection site (CIDP).

HyQvia: Administer the two components of HyQvia (immune globulin and hyaluronidase) sequentially, beginning with the hyaluronidase; do not use either component alone. Infusion pump capable of infusing rates up to 300 mL/hour/site required; must also have the ability to titrate the flow rate. Use a 24-gauge subcutaneous needle set labeled for high flow rates. Infusion site leakage can occur; consider using longer needles (14 mm or 12 mm) and/or more than one infusion site. Initiate the infusion of the full dose of the immune globulin through the same subcutaneous needle set within ~10 minutes of hyaluronidase infusion. For each full or partial vial of immune globulin used, administer the entire contents of the hyaluronidase vial. A second site can be used based on tolerability and total volume; if a second site is used, it should be placed on the opposite side of the body; administer half of total volume of the hyaluronidase in each site. Flush the infusion line with NS or D5W if required.

Injection sites: Middle to upper abdomen or thigh (avoid bony prominences or areas that are scarred, inflamed, or infected).

Volume per site:

<40 kg: ≤300 mL per injection site.

≥40 kg: ≤600 mL per injection site.

Infusion rate:

Immune globulin:

First 2 infusions:

<40 kg: 5 mL/hour for 5 to 15 minutes; 10 mL/hour for 5 to 15 minutes; 20 mL/hour for 5 to 15 minutes; 40 mL/hour for 5 to 15 minutes; then 80 mL/hour for remainder of infusion.

≥40 kg: 10 mL/hour for 5 to 15 minutes; 30 mL/hour for 5 to 15 minutes; 60 mL/hour for 5 to 15 minutes; 120 mL/hour for 5 to 15 minutes; then 240 mL/hour for remainder of infusion.

Next 2 or 3 infusions:

<40 kg: 10 mL/hour for 5 to 15 minutes; 20 mL/hour for 5 to 15 minutes; 40 mL/hour for 5 to 15 minutes; 80 mL/hour for 5 to 15 minutes; then 160 mL/hour for remainder of infusion.

≥40 kg: 10 mL/hour for 5 to 15 minutes; 30 mL/hour for 5 to 15 minutes; 120 mL/hour for 5 to 15 minutes; 240 mL/hour for 5 to 15 minutes; then 300 mL/hour for remainder of infusion.

Xembify: Note: It is recommended that infusion be complete within 2 hours of preparation to avoid the potential formation of particles caused by siliconized syringes.

Injection sites: Abdomen, thigh, upper arm, sides, back, and/or lateral hip (avoid bony prominence or areas that are scarred, inflamed, or infected); ≤6 simultaneous injection sites (spaced ≥2 inches apart).

Maximum infusion rate: 25 mL/hour per injection site.

Maximum infusion volume: 25 mL per injection site.

Use: Labeled Indications

Antiviral prophylaxis: GamaSTAN, GamaSTAN S/D [Canadian product]: Provision of passive immunity in the following situations:

Hepatitis A: Preexposure prophylaxis and postexposure prophylaxis within 14 days of exposure and/or prior to manifestation of disease.

Measles: For use within 6 days of exposure in an unvaccinated person who has not previously had measles.

Advisory Committee on Immunization Practices recommendations: The Advisory Committee on Immunization Practices recommends postexposure prophylaxis with immune globulin (IG) to any nonimmune person exposed to measles. The following patient groups are at risk for severe measles complications and should receive IG therapy: Infants <12 months of age, pregnant patients without evidence of immunity; severely compromised persons (eg, persons with severe primary immunodeficiency; some bone marrow transplant recipients; some acute lymphocytic leukemia patients; and some patients with AIDS or HIV infection [refer to guidelines for additional details]). Although prophylaxis may be given to any nonimmune person, priority should be given to those at greatest risk for measles complications and also to persons exposed in settings with intense, prolonged, close contact (eg, households, daycare centers, classrooms). IG therapy is not indicated for any person who already received one dose of a measles-containing vaccine at ≥12 months of age unless they are severely immunocompromised (CDC 2013).

Varicella: For immunosuppressed patients when varicella zoster immune globulin is not available.

Chronic inflammatory demyelinating polyneuropathy: Gammaked, Gamunex-C, Hizentra, Panzyga, Privigen: Treatment of chronic inflammatory demyelinating polyneuropathy.

Dermatomyositis/Polymyositis , severe, life-threatening o r refractory: Octagam 10%: Treatment of dermatomyositis in adults.

Hypogammaglobulinemia, prophylaxis against bacterial infection: Asceniv, Bivigam, Carimune NF, Cutaquig, Cuvitru, Flebogamma DIF, HyQvia, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Hizentra, Octagam 5%, Panzyga, Privigen, Xembify: Prevention of bacterial infection in patients with hypogammaglobulinemia and/or recurrent bacterial infections with malignancy (eg, B-cell chronic lymphocytic leukemia) or primary humoral immunodeficiency disorders.

Immune thrombocytopenia:

Carimune NF, Gammaked, Gamunex-C: Treatment of acute immune thrombocytopenia (ITP).

Carimune NF, Flebogamma DIF 10%, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam 10%, Panzyga, Privigen: Treatment of chronic ITP.

Kawasaki syndrome: Gammagard S/D: Prevention of coronary artery aneurysms associated with Kawasaki syndrome (in combination with aspirin).

Multifocal motor neuropathy: Gammagard Liquid: Treatment of multifocal motor neuropathy.

Use: Off-Label: Adult

Antibody-mediated rejection, treatment, heart transplantation; Antibody-mediated rejection, treatment, kidney transplantation; Antibody-mediated rejection, treatment, lung transplantation; Encephalomyelitis, acute disseminated; Guillain-Barré syndrome; Hypogammaglobulinemia, prophylaxis against bacterial infection, hematopoietic cell transplantation; Lambert-Eaton myasthenic syndrome; Myasthenia gravis, acute exacerbation; Parvovirus B19 infection, treatment, immunocompromised host; Pemphigus foliaceus and vulgaris, refractory; Toxic shock syndrome, streptococcal; Warm autoimmune hemolytic anemia

Medication Safety Issues
Sound-alike/look-alike issues:

Gamimune N may be confused with CytoGam

Immune globulin (intravenous) may be confused with hepatitis B immune globulin

Privigen (immune globulin) may be confused with Albuminar-25 (albumin) due to similar packaging

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse effects are reported as class effects rather than for specific products in adult and pediatric patients.

>10%:

Cardiovascular: Chest pain, decreased heart rate, hypertension, hypotension, increased heart rate, tachycardia

Dermatologic: Dermatitis, ecchymoses, injection site pruritus

Gastrointestinal: Abdominal pain, diarrhea, nausea, upper abdominal pain, viral gastroenteritis, vomiting

Hematologic & oncologic: Anemia, hemolysis, positive direct Coombs test

Hepatic: Increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum bilirubin (increased direct serum bilirubin or increased indirect serum bilirubin)

Immunologic: Antibody development

Local: Bruising at injection site, erythema at injection site, injection site nodule, irritation at injection site, pain at injection site, swelling at injection site

Nervous system: Chills, dizziness, fatigue, headache, increased body temperature, pain, rigors

Neuromuscular and skeletal: Asthenia, back pain, limb pain, myalgia

Respiratory: Asthma, bronchitis, cough, epistaxis, nasal congestion, nasopharyngitis, pharyngitis, rhinitis, sinusitis (including acute sinusitis), upper respiratory tract infection, wheezing

Miscellaneous: Fever

1% to 10%:

Cardiovascular: Chest discomfort, flushing, heart murmur, peripheral edema

Dermatologic: Allergic dermatitis, eczema, erythema of skin, hyperhidrosis, pruritus, skin rash, urticaria, xeroderma

Endocrine & metabolic: Dehydration, increased lactate dehydrogenase, thyroiditis

Gastrointestinal: Abdominal distention, aphthous stomatitis, dyspepsia, flatulence, gastritis, stomach discomfort

Genitourinary: Cystitis, dysuria, urinary tract infection

Hematologic & oncologic: Bruise, hematoma, hemolytic anemia, leukopenia, neutropenia

Hepatic: Increased serum aspartate aminotransferase

Hypersensitivity: Hypersensitivity reaction

Infection: Influenza, viral infection

Local: Induration at injection site, inflammation at injection site

Nervous system: Depression, falling, fibromyalgia syndrome (exacerbation), hypertonia, lethargy, malaise, migraine, myasthenia, sensation of cold, vertigo

Neuromuscular & skeletal: Arthralgia, joint effusion, joint swelling, muscle spasm, musculoskeletal pain, neck pain

Otic: Otalgia

Respiratory: Dyspnea, flu-like symptoms, oropharyngeal pain, pharyngolaryngeal pain, pneumonia, viral upper respiratory tract infection

<1%:

Cardiovascular: Transient ischemic attacks

Gastrointestinal: Anorexia

Infection: Subcutaneous abscess

Nervous system: Anxiety, aseptic meningitis, chronic inflammatory demyelinating polyneuropathy (exacerbation)

Renal: Nephrolithiasis

Frequency not defined:

Cardiovascular: Facial flushing, thrombosis

Dermatologic: Cellulitis, diaphoresis, localized erythema, papule of skin, urticaria at injection site

Genitourinary: Proximal tubular nephropathy

Hematologic & oncologic: Exacerbation of autoimmune pure red cell aplasia, hyperproteinemia, increased serum immunoglobulins (hyperviscosity), local hemorrhage

Local: Hematoma at injection site, local irritation, residual mass at injection site

Nervous system: Drowsiness

Neuromuscular & skeletal: Lower limb cramp

Ophthalmic: Blurred vision

Renal: Increased blood urea nitrogen, increased serum creatinine, renal tubular necrosis

Respiratory: Bronchopneumonia, non-cardiogenic pulmonary edema

Postmarketing:

Cardiovascular: Acute myocardial infarction, angina pectoris, arterial thrombosis, bradycardia, cerebrovascular accident, circulatory shock, deep vein thrombosis, edema, facial edema, hot and cold flashes, oxygen saturation decreased, palpitations, peripheral vascular insufficiency, phlebitis, pulmonary embolism, syncope, thromboembolism, thrombophlebitis, venous thrombosis (retinal vein thrombosis)

Dermatologic: Alopecia, bullous dermatitis, epidermolysis, erythema multiforme, erythematous rash, exfoliation of skin, pallor, rash at injection site, skin discoloration, skin ulceration at injection site, Stevens-Johnson syndrome

Endocrine & metabolic: Decreased haptoglobins, hypervolemia, hyponatremia (Daphnis 2007; Nguyen 2006; Steinberger 2003), pseudohyponatremia (Daphnis 2007; Nguyen 2006; Steinberger 2003), translocational hyponatremia (Daphnis 2007; Nguyen 2006; Steinberger 2003)

Gastrointestinal: Oral paresthesia

Genitourinary: Hematuria, hemoglobinuria, osmotic nephrosis, urine discoloration

Hematologic & oncologic: Acute intravascular hemolysis, decreased neutrophils, disseminated intravascular coagulation, increased hemoglobin, lymphadenopathy, pancytopenia, thrombocytopenia

Hepatic: Hepatic insufficiency, hepatitis (noninfectious)

Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, nonimmune anaphylaxis

Local: Tissue necrosis at injection site, warm sensation at injection site

Nervous system: Agitation, burning sensation, coma, confusion, hypoesthesia, loss of consciousness, nervousness, paresthesia, restlessness, seizure, speech disturbance, voice disorder

Neuromuscular & skeletal: Laryngospasm, muscle rigidity, polymyositis, tremor

Ophthalmic: Eye pain, photophobia, visual disturbance

Renal: Acute kidney injury, renal failure syndrome, renal insufficiency, renal pain

Respiratory: Acute respiratory distress syndrome, apnea, bronchospasm, cyanosis, hyperventilation, hypoxemia, hypoxia, pharyngeal edema, pulmonary edema, respiratory failure, transfusion-related acute lung injury

Contraindications

Hypersensitivity to immune globulin or any component of the formulation; IgA deficiency (with anti-IgA antibodies and history of hypersensitivity [excluding Gammagard S/D]); hyperprolinemia (Hizentra, Privigen); hypersensitivity to corn (Octagam 5%); hereditary intolerance to fructose (Gammaplex 5%); infants/neonates for whom sucrose or fructose tolerance has not been established (Gammaplex 5%); hypersensitivity to hyaluronidase, human albumin, or any component of the hyaluronidase formulation (HyQvia).

Canadian labeling: Additional contraindications (not in US labeling): GamaSTAN S/D: Severe thrombocytopenia or coagulation disorders where IM injections are contraindicated.

Documentation of allergenic cross-reactivity for immune globulins is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions can occur (some severe); patients with known antibodies to IgA are at greater risk; a severe fall in blood pressure may rarely occur with anaphylactic reaction; discontinue therapy and institute immediate treatment (including epinephrine 1 mg/mL) should be available.

• Aseptic meningitis: Aseptic meningitis syndrome (AMS) has been reported with immune globulin administration; may occur with high doses (≥1 g/kg) and/or rapid infusion. Syndrome usually appears within several hours to 2 days following treatment; usually resolves within several days after product is discontinued. Female patients or patients with a migraine history may be at higher risk for AMS.

• Hematoma: Do not administer subcutaneously for the treatment of immune thrombocytopenia because of the risk of hematoma formation.

• Hemolysis: Intravenous immune globulin has been associated with antiglobulin hemolysis (acute or delayed). Cases of hemolysis-related renal impairment/failure or disseminated intravascular coagulation have been reported. Risk factors associated with hemolysis include high doses (≥2 g/kg) given either as a single administration or divided over several days, underlying associated inflammatory conditions, and non-O blood type (FDA 2012). An underlying inflammatory state (eg, elevated C-reactive protein or erythrocyte sedimentation rate) may also increase the risk. Closely monitor patients for signs of hemolytic anemia, particularly in patients with preexisting anemia and/or cardiovascular or pulmonary compromise.

• Hereditary fructose intolerance: Immune globulin may contain sorbitol. The presence of sorbitol presents a risk to those with hereditary fructose intolerance (HFI). The incidence of HFI is estimated at 1 in 20,000 births and is usually diagnosed at the time of weaning when fructose or sucrose is introduced into the diet. Clinical symptoms include recurrent vomiting, abdominal pain, and hypoglycemia. Immune globulin containing sorbitol must not be administered to patients with HFI.

• Hyperproteinemia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur; distinguish hyponatremia from pseudohyponatremia to prevent volume depletion, a further increase in serum viscosity and a higher risk of thrombotic events.

• Hypertension: Elevations of blood pressure (systolic ≥180 mm Hg and/or diastolic >120 mm Hg) have been observed during and/or shortly following infusion of Panzyga and Privigen, which resolved with either observation or changes in oral antihypertensive therapy.

• Infusion reactions: Patients should be monitored for adverse events during and after the infusion. Stop administration with signs of infusion reaction (fever, chills, nausea, vomiting, and rarely shock). Risk may be increased with initial treatment, when switching brands of immune globulin, and with treatment interruptions of >8 weeks.

• Pulmonary edema: Monitor for transfusion-related acute lung injury (TRALI); noncardiogenic pulmonary edema has been reported with immune globulin use. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, and fever in the presence of normal left ventricular function. Usually occurs within 1 to 6 hours after infusion.

• Renal dysfunction and acute renal failure: [US Boxed Warning]: IV administration only: Acute renal dysfunction (increased serum creatinine, oliguria, acute renal failure, osmotic nephrosis) can rarely occur and has been associated with fatalities in predisposed patients. Patients predisposed to renal dysfunction include elderly patients, patients with renal disease, diabetes mellitus, hypovolemia, volume depletion, sepsis, paraproteinemia, and nephrotoxic medications due to risk of renal dysfunction. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. (Note: The following IV products do not contain sucrose: Asceniv, Bivigam, Flebogamma DIF, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Octagam 5%, Octagam 10%, Panzyga, and Privigen). In patients at risk of renal dysfunction or acute renal failure, ensure adequate hydration prior to administration; the dose, rate of infusion, and concentration of solution should be minimized. Assess renal function prior to treatment and periodically thereafter. Discontinue if renal function deteriorates.

• Thromboembolic events: [US Boxed Warning]: Thrombosis may occur with immune globulin products even in the absence of risk factors for thrombosis. For patients at risk of thrombosis (eg, advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors), administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity, such as those with cryoglobulins, fasting chylomicronemia/severe hypertriglyceridemia, or monoclonal gammopathies.

Disease-related concerns:

• Fluid overload: High-dose regimens (1 g/kg for 1 to 2 days) are not recommended for individuals with fluid overload or where fluid volume may be of concern.

• IgA deficiency: Increased risk of hypersensitivity, especially in patients with anti-IgA antibodies; use is contraindicated in patients with IgA deficiency (with antibodies against IgA and history of hypersensitivity) or isolated IgA deficiency (GamaSTAN S/D [Canadian product]).

• Renal impairment: Use with caution; ensure adequate hydration prior to administration; the rate of infusion and concentration of solution should be minimized.

Special populations:

• Older adult: Use with caution in elderly patients; may be at increased risk for renal dysfunction/failure and thromboembolic events.

Dosage form specific issues:

• Human plasma: Product of human plasma; may potentially contain infectious agents (eg, viruses, the variant Creutzfeldt Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt Jakob disease [CJD] agent) that could transmit disease, including unknown or emerging viruses and other pathogens. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.

• L-proline: Hizentra and Privigen contain the stabilizer L-proline and are contraindicated in patients with hyperprolinemia.

• Maltose: Some products may contain maltose, which may result in falsely elevated blood glucose readings. Maltose-containing products may be contraindicated with patients with corn allergy.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

• Skin testing: Skin testing should not be performed with GamaSTAN or GamaSTAN S/D [Canadian product] as local irritation can occur and be misinterpreted as a positive reaction.

• Sodium: Some products may contain sodium.

• Sorbitol: Some products may contain sorbitol; do not use immune globulin in patients with hereditary fructose intolerance.

• Sucrose: Some products may contain sucrose.

Other warnings/precautions:

• Administration: Do not infuse into or around an infected area due to the risk of spreading a localized infection.

• High-dose regimen: Consider risk versus benefit for high-dose regimen in patients with increased risk of thrombosis, hemolysis, acute kidney injury, or volume overload.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Estrogen Derivatives: May enhance the thrombogenic effect of Immune Globulin. Risk C: Monitor therapy

Ravulizumab: Immune Globulin may decrease the serum concentration of Ravulizumab. Management: Administer a supplemental dose of ravulizumab (600 mg) within 4 hours of completion of the immune globulin cycle. Risk D: Consider therapy modification

Vaccines (Live): Immune Globulins may diminish the therapeutic effect of Vaccines (Live). Management: Live organism vaccination should be withheld for as long as 6 to 11 months following immune globulin administration. Recommendations vary by product and immune globulin dose, see full monograph for details. Risk D: Consider therapy modification

Pregnancy Considerations

Placental transfer of human IgG is dependent upon the IgG subclass and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009). In a study of two women treated with IV immune globulin (IVIG) for common variable immunodeficiency, exogenous immune globulin was shown to cross the placenta similar to endogenous immune globulin (Palmeira 2012).

IV immune globulin has been recommended for use in fetal-neonatal alloimmune thrombocytopenia and pregnancy-associated immune thrombocytopenia (ITP) (ACOG 207 2019; Anderson 2007; Neunert 2011); use is appropriate for ITP in cases refractory to corticosteroids, when side effects to corticosteroids are significant, or when a rapid increase in platelets is needed (ACOG 207 2019). Intravenous immune globulin is recommended to prevent measles in nonimmune women exposed during pregnancy (CDC 2013). May also be used in postexposure prophylaxis for rubella to reduce the risk of infection and fetal damage in exposed pregnant females who will not consider therapeutic abortion (per GamaSTAN product labeling; use for postexposure rubella prophylaxis is not currently recommended [CDC 2013]). IV immune globulin may be used when a prompt response for the treatment of myasthenia gravis is needed during pregnancy (Sanders 2016).

HyQvia: Data collection to monitor pregnancy and infant outcomes following exposure to HyQvia is ongoing. Patients may enroll themselves in the HyQvia pregnancy registry by calling (866) 424-6724.

Breastfeeding Considerations

Immune globulin is endogenous to breast milk.

In a study of two women treated with IV immune globulin (IVIG) for common variable immunodeficiency, the colostrum of one mother with IgA deficiency was found to provide similar IgA immunological protection as mothers without a deficiency (Palmeira 2012).

According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Immune globulin is considered compatible with breastfeeding (WHO 2002).

Dietary Considerations

Some products may contain sodium.

Monitoring Parameters

Renal function (prior to initial infusion and at appropriate intervals), urine output, IgG concentrations, hemoglobin and hematocrit, platelets (in patients with ITP); infusion- or injection-related adverse reactions, anaphylaxis, signs and symptoms of thrombosis, signs and symptoms of hemolysis; blood viscosity (in patients at risk for hyperviscosity); presence of antineutrophil antibodies (if TRALI is suspected); volume status; neurologic symptoms (if AMS suspected); pulmonary adverse reactions; blood pressure (prior to, during, and following infusion); clinical response.

For patients at high risk of hemolysis (dose ≥2 g/kg, given as a single dose or divided over several days, and non-O blood type): Hemoglobin or hematocrit prior to and 36 to 96 hours post-infusion and again at 7 to 10 days post-infusion.

SUBQ infusion: For treatment of primary humoral immunodeficiency, monitor IgG trough levels every 2 to 3 months before/after conversion from IV; subcutaneous infusions provide more constant IgG levels than usual IV immune globulin treatments.

Mechanism of Action

Replacement therapy for primary and secondary immunodeficiencies, and IgG antibodies against bacteria, viral, parasitic and mycoplasma antigens; interference with Fc receptors on the cells of the reticuloendothelial system for autoimmune cytopenias and ITP; provides passive immunity by increasing the antibody titer and antigen-antibody reaction potential

Pharmacokinetics

Onset of action: IV: Provides immediate antibody levels.

Immune thrombocytopenia: Initial response: 1 to 3 days; Peak response: 2 to 7 days (Neunert 2011).

Duration: IM, IV: Immune effect: 3 to 4 weeks (variable).

Distribution: Vd: 0.05 to 0.13 L/kg.

Intravascular portion (primarily): Healthy subjects: 41% to 57%; Patients with congenital humoral immunodeficiencies: ~70%.

Half-life elimination: IM: ~23 days; SUBQ: ~59 days (HyQvia); IV: IgG (variable among patients): Healthy subjects: 14 to 24 days; Patients with congenital humoral immunodeficiencies: 26 to 40 days; hypermetabolism associated with fever and infection have coincided with a shortened half-life.

Time to peak:

Plasma: SUBQ: Cutaquig: ~2 days; Cuvitru: ~4.4 days; Gammagard Liquid: 2.9 days; Hizentra: 2.9 days; HyQvia: ~5 days; Xembify: ~3 days.

Serum: IM: ~48 hours.

Pricing: US

Kit (Hyqvia Subcutaneous)

2.5 g/25 mL (per mL): $25.38

5 gm/50 mL (per mL): $25.38

10 g/100 mL (per mL): $25.38

20 g/200 mL (per mL): $25.38

30 g/300 mL (per mL): $25.38

Solution (Asceniv Intravenous)

5 gm/50 mL (per mL): $111.26

Solution (Bivigam Intravenous)

5 gm/50 mL (per mL): $16.52

10 g/100 mL (per mL): $16.52

Solution (Cutaquig Subcutaneous)

1GM/6ML (per mL): $38.87

1.65 g/10 mL (per mL): $38.48

2GM/12ML (per mL): $38.87

3.3 g/20 mL (per mL): $38.48

4GM/24ML (per mL): $38.87

8GM/48ML (per mL): $38.87

Solution (Cuvitru Subcutaneous)

1 g/5 mL (per mL): $48.40

2 g/10 mL (per mL): $48.40

4 g/20 mL (per mL): $48.40

8 g/40mL (per mL): $48.40

10 gm/50 mL (per mL): $48.40

Solution (Flebogamma DIF Intravenous)

0.5 g/10 mL (per mL): $6.35

2.5 gm/50 mL (per mL): $6.35

5 g/100 mL (per mL): $6.35

5 gm/50 mL (per mL): $12.71

10 g/100 mL (per mL): $12.71

10 g/200 mL (per mL): $6.35

20 g/200 mL (per mL): $12.71

20 g/400 mL (per mL): $6.35

Solution (Gammagard Injection)

1 g/10 mL (per mL): $18.63

2.5 g/25 mL (per mL): $18.63

5 gm/50 mL (per mL): $18.63

10 g/100 mL (per mL): $18.63

20 g/200 mL (per mL): $18.63

30 g/300 mL (per mL): $18.63

Solution (Gammaked Injection)

1 g/10 mL (per mL): $20.95

5 gm/50 mL (per mL): $20.94

10 g/100 mL (per mL): $20.94

20 g/200 mL (per mL): $20.94

Solution (Gammaplex Intravenous)

5 g/100 mL (per mL): $11.85

5 gm/50 mL (per mL): $23.70

10 g/100 mL (per mL): $23.70

10 g/200 mL (per mL): $11.85

20 g/200 mL (per mL): $23.70

20 g/400 mL (per mL): $11.85

Solution (Gamunex-C Injection)

1 g/10 mL (per mL): $16.41

2.5 g/25 mL (per mL): $16.41

5 gm/50 mL (per mL): $16.41

10 g/100 mL (per mL): $16.41

20 g/200 mL (per mL): $16.41

40 g/400 mL (per mL): $16.41

Solution (Hizentra Subcutaneous)

1 g/5 mL (per mL): $49.49

2 g/10 mL (per mL): $49.49

4 g/20 mL (per mL): $49.49

10 gm/50 mL (per mL): $49.49

Solution (Octagam Intravenous)

1 g/20 mL (per mL): $10.78

2 g/20 mL (per mL): $21.55

2.5 gm/50 mL (per mL): $10.78

5 g/100 mL (per mL): $10.78

5 gm/50 mL (per mL): $21.55

10 g/100 mL (per mL): $21.55

10 g/200 mL (per mL): $10.78

20 g/200 mL (per mL): $21.55

30 g/300 mL (per mL): $21.55

Solution (Panzyga Intravenous)

1 g/10 mL (per mL): $23.86

2.5 g/25 mL (per mL): $23.86

5 gm/50 mL (per mL): $23.86

10 g/100 mL (per mL): $23.86

20 g/200 mL (per mL): $23.86

30 g/300 mL (per mL): $23.86

Solution (Privigen Intravenous)

5 gm/50 mL (per mL): $19.51

10 g/100 mL (per mL): $19.51

20 g/200 mL (per mL): $19.51

40 g/400 mL (per mL): $19.51

Solution (Xembify Subcutaneous)

1 g/5 mL (per mL): $42.29

2 g/10 mL (per mL): $42.29

4 g/20 mL (per mL): $42.29

10 gm/50 mL (per mL): $42.29

Solution (reconstituted) (Gammagard S/D Less IgA Intravenous)

5 g (per each): $1,244.04

10 g (per each): $2,488.08

Solution Prefilled Syringe (Hizentra Subcutaneous)

1 g/5 mL (per mL): $49.49

2 g/10 mL (per mL): $49.49

4 g/20 mL (per mL): $49.49

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Allerglobuline (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW);
  • Aragam (GB);
  • Aunativ (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE);
  • Beriglobin (AE, AT, BH, CH, CY, DE, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SE, SY, YE);
  • Beriglobin P (AR);
  • Beriglobina (BR, ES);
  • Beriglobina P (CL);
  • Endobulin (CZ, FI);
  • Flebogamma (HK, IL, MY, SG, TH);
  • Gamastan (HK);
  • Gamastan Immune Globulin (IL);
  • Gamimune (QA);
  • Gamma 16 (IL);
  • Gamma I.V. (IN, PH);
  • Gammagard (BG, DK, ES, FR, GB, HN, IT, NL, PL, SE);
  • Gammagard S/D (HK, IL, SA);
  • Gammanorm (AE, FR, GB);
  • Gammaplex (GB);
  • Gammonativ (AE, BH, CY, DE, DK, EG, IQ, IR, JO, KW, LB, LY, NO, OM, QA, SA, SE, SY, YE);
  • Gamunex (AE, CY, ID, IL);
  • Gamunex C (SG);
  • Gamunex-C (HK, MY, TH);
  • Globuman Berna (PH);
  • Hizentra (AR, AT, AU, BE, BR, CH, CZ, DE, DK, EC, EE, ES, FI, FR, GB, GR, HK, HR, HU, IE, JP, KR, LB, LT, LU, LV, NL, NO, NZ, PE, PL, PT, RO, SE, TR);
  • Humaglobin (VN);
  • Humoglob (PH);
  • I.V.-Globulin SN (PH);
  • IG Gamma (IL);
  • IG Vena (HK, PH);
  • Ig Vena NIV (ID);
  • Immunorel (PH);
  • Intragam P (AU, HK, ID);
  • Intraglobin (CH, DE, IT);
  • Intraglobin F (IL);
  • Intratect (GB, HK, ID);
  • IV Globulin-S (KR);
  • Kiovig (AT, AU, BE, BG, CH, CZ, DE, DK, EE, FI, FR, GB, GR, HK, HN, IE, IL, IT, MT, NL, NO, PL, PT, RU, SE, SK, TR);
  • Klovig (TH);
  • Octagam (AT, AU, BE, BG, BH, BR, CH, CO, CZ, DE, DK, EE, FI, FR, GB, GR, HR, ID, IN, LB, LT, MT, MX, NL, NO, NZ, PH, PL, RO, SA, SE, SI, SK, TH, UY, VN);
  • Panzyga (AT, AU, CZ, DK, ES, GB, HU, LT, LU, NO, PT, SK);
  • Pentaglobin (AT, DE, SG, TH, VN);
  • Privigen (IL, JP);
  • Sandoglobulin (AE, BH, CZ, DK, EG, FI, GR, IL, LB, LK, NO, NZ, PK, QA);
  • Sandoglobulina (CO, IT, PE);
  • Subcuvia (FR, GB);
  • Subgam (GB, IE);
  • Tegeline (LB);
  • Vena IG (LK);
  • Vigam (TH)


For country code abbreviations (show table)
  1. Abougergi MS and Kwon JH, "Intravenous Immunoglobulin for the Treatment of Clostridium difficile Infection: A Review," Dig Dis Sci, 2011, 56(1):19-26. [PubMed 20924675]
  2. Abraham D, Kalyanasundaram S, Krishnamurthy K. Refractory Kawasaki disease-a challenge for the pediatrician. SN Compr Clin Med. 2021;3(3):855-860. doi:10.1007/s42399-021-00775-w [PubMed 33532696]
  3. Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  4. Amagai M, Ikeda S, Shimizu H, et al; Pemphigus Study Group. A randomized double-blind trial of intravenous immunoglobulin for pemphigus. J Am Acad Dermatol. 2009;60(4):595-603. doi:10.1016/j.jaad.2008.09.052 [PubMed 19293008]
  5. American Academy of Pediatrics (AAP). In: Kimberlin DW, Brady MT, Jackson MA, Long SA, eds. Red Book: 2018 Report of the Committee on Infectious Diseases. 31st ed. Itasca, IL: American Academy of Pediatrics; 2018.
  6. American Academy of Pediatrics (AAP). In: Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH, eds. Red Book: 2021 Report of the Committee on Infectious Diseases. 32nd ed. American Academy of Pediatrics; 2021.
  7. American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation. Pediatrics. 2004;114(1):297-316. [PubMed 15231951]
  8. American College of Obstetricians and Gynecologists. ACOG Practice Bulletin No. 207: thrombocytopenia in pregnancy. Obstet Gynecol. 2019;133(3):e181-e193. doi:10.1097/AOG.0000000000003100 [PubMed 30801473]
  9. Anderson D, Ali K, Blanchette V, et al. Guidelines on the use of intravenous immune globulin for hematologic conditions. Transfus Med Rev. 2007;21(2)(suppl 1):s9-s56. [PubMed 17397769]
  10. Arnold DM. Immune thrombocytopenia (ITP) in adults: initial treatment and prognosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed October 5, 2021.
  11. Asceniv (immune globulin intravenous [human]) [prescribing information]. Boca Raton, FL: ADMA Biologics; April 2019.
  12. ASHP Commission on Therapeutics. ASHP Therapeutic Guidelines for Intravenous Immune Globulin. Am J Hosp Pharm. 1992;49(3):652-654. [PubMed 1598949]
  13. Bain PG, Motomura M, Newsom-Davis J, et al. Effects of intravenous immunoglobulin on muscle weakness and calcium-channel autoantibodies in the Lambert-Eaton myasthenic syndrome. Neurology. 1996;47(3):678-683. [PubMed 8797464]
  14. Ballow M, Shehata N. Overview of intravenous immune globulin (IVIG) therapy. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed August 17, 2021.
  15. Barth D, Nabavi Nouri M, Ng E, Nwe P, Bril V. Comparison of IVIg and PLEX in patients with myasthenia gravis. Neurology. 2011;76(23):2017-2023. [PubMed 21562253]
  16. Based on expert opinion.
  17. Bassan H, Muhlbaur B, Tomer A, et al, "High-Dose Intravenous Immunoglobulin in Transient Neonatal Myasthenia Gravis," Pediatr Neurol, 1998, 18(2):181-3. [PubMed 9535308]
  18. Bonilla FA, Bernstein IL, Khan DA, et al. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol. 2005;94(5 Suppl 1):S1-63. [PubMed 15945566]
  19. Bonilla FA, Khan DA, Ballas ZK, et al; Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology; the American College of Allergy, Asthma & Immunology; and the Joint Council of Allergy, Asthma & Immunology. Practice parameter for the diagnosis and management of primary immunodeficiency. J Allergy Clin Immunol. 2015;136(5):1186-1205.e1-78. doi:10.1016/j.jaci.2015.04.049 [PubMed 26371839]
  20. Bivigam (immune globulin intravenous [human]) [prescribing information]. Boca Raton, FL: Biotest Pharmaceuticals Corporation; July 2019.
  21. Brennan J, Moore K, Sizemore L, et al. Notes from the field: acute hepatitis A virus infection among previously vaccinated persons with HIV infection - Tennessee, 2018. MMWR Morb Mortal Wkly Rep. 2019;68(14):328-329. doi:10.15585/mmwr.mm6814a3 [PubMed 30973852]
  22. British Committee for Standards in Haematology General Haematology Task Force. Guidelines for the investigation and management of idiopathic thrombocytopenic purpura in adults, children and in pregnancy. Br J Haematol. 2003;120(4):574-596. doi:10.1046/j.1365-2141.2003.04131.x [PubMed 12588344]
  23. Brodsky RA. Warm autoimmune hemolytic anemia. N Engl J Med. 2019;381(7):647-654. doi:10.1056/NEJMcp1900554 [PubMed 31412178]
  24. Brugnara C, Brodsky RA. Warm autoimmune hemolytic anemia (AIHA) in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed May 25, 2022.
  25. Carimune (immune globulin intravenous [human]) [prescribing information]. Kankakee, IL: CSL Behring AG; November 2016.
  26. Carimune NF (immune globulin intravenous [human]) [prescribing information]. Kankakee, IL: CSL Behring LLC; May 2018.
  27. Cattalini M, Taddio A, Bracaglia C, et al. Childhood multisystem inflammatory syndrome associated with COVID-19 (MIS-C): a diagnostic and treatment guidance from the Rheumatology Study Group of the Italian Society of Pediatrics. Ital J Pediatr. 2021;47(1):24. doi:10.1186/s13052-021-00980-2 [PubMed 33557873]
  28. Centers for Disease Control and Prevention (CDC). Control and prevention of rubella: evaluation and management of suspected outbreaks, rubella in pregnant women, and surveillance for congenital rubella syndrome. MMWR Recomm Rep. 2001;50(RR-12):1-23. [PubMed 11475328]
  29. Centers for Disease Control and Prevention (CDC). Hepatitis A Questions and Answers for Health Professionals. Updated October 2017. https://www.cdc.gov/hepatitis/hav/havfaq.htm. Accessed October 10, 2017.
  30. Centers for Disease Control and Prevention (CDC). Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006;55(RR-7):1-23. http://www.cdc.gov/mmwr/PDF/rr/rr5507.pdf. [PubMed 16708058]
  31. Centers for Disease Control and Prevention (CDC). Prevention of measles, rubella, congenital rubella syndrome, and mumps, 2013: summary recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2013;62(RR-04):1-34. [PubMed 23760231]
  32. Centers for Disease Control and Prevention (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm. [PubMed 6423951]
  33. Centers for Disease Control and Prevention (CDC). Updated dosing instructions for immune globulin (human) GamaSTAN S/D for hepatitis A virus prophylaxis. MMWR Morb Mortal Wkly Rep. 2017;66(36):959-960. [PubMed 28910270]
  34. Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices (ACIP). Update: prevention of hepatitis A after exposure to hepatitis A virus and in international travelers. Updated recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2007;56(41):1080-1084. [PubMed 17947967]
  35. Chapel HM, Lee M, Hargreaves R, Pamphilon DH, Prentice AG. Randomised trial of intravenous immunoglobulin as prophylaxis against infection in plateau-phase multiple myeloma. The UK Group for Immunoglobulin Replacement Therapy in Multiple Myeloma. Lancet. 1994;343(8905):1059-1063. [PubMed 7909099]
  36. Cherin P, Pelletier S, Teixeira A, et al. Results and long-term followup of intravenous immunoglobulin infusions in chronic, refractory polymyositis: an open study with thirty-five adult patients. Arthritis Rheum. 2002;46(2):467-474. doi:10.1002/art.10053 [PubMed 11840450]
  37. Colvin MM, Cook JL, Chang P, et al; American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical Cardiology; American Heart Association Heart Failure and Transplantation Committee of the Council on Cardiopulmonary Critical Care, Perioperative and Resuscitation; American Heart Association Heart Failure and Transplantation Committee of the Council on Cardiovascular Disease in the Young; et al. Antibody-mediated rejection in cardiac transplantation: emerging knowledge in diagnosis and management: a scientific statement from the American Heart Association. Circulation. 2015;131(18):1608-1639. [PubMed 25838326]
  38. Costanzo MR, Dipchand A, Starling R, et al; International Society of Heart and Lung Transplantation Guidelines. The International Society of Heart and Lung Transplantation guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2010;29(8):914-956. doi:10.1016/j.healun.2010.05.034 [PubMed 20643330]
  39. Cutaquig (immune globulin subcutaneous human) [prescribing information]. Paramus, NJ: Octapharma USA Inc; October 2021.
  40. Cutaquig (immune globulin subcutaneous human) [prescribing information]. New York, NY: Pfizer Labs; November 2021.
  41. Cutaquig (immune globulin subcutaneous human) [product monograph]. Toronto, Ontario, Canada: Octapharma Canada Inc; June 2021.
  42. Cuvitru (immune globulin subcutaneous [human]) [prescribing information]. Lexington, MA: Baxalta US Inc; September 2021.
  43. Czernik A, Beutner EH, Bystryn JC. Intravenous immunoglobulin selectively decreases circulating autoantibodies in pemphigus. J Am Acad Dermatol. 2008;58(5):796-801. doi:10.1016/j.jaad.2008.01.007 [PubMed 18423257]
  44. Dalakas MC, Illa I, Dambrosia JM, et al. A controlled trial of high-dose intravenous immune globulin infusions as treatment for dermatomyositis. N Engl J Med. 1993;329(27):1993-2000. [PubMed 8247075]
  45. Danieli MG, Pettinari L, Moretti R, Logullo F, Gabrielli A. Subcutaneous immunoglobulin in polymyositis and dermatomyositis: a novel application. Autoimmun Rev. 2011;10(3):144-149. doi:10.1016/j.autrev.2010.09.004 [PubMed 20858553]
  46. Dantal J. Intravenous immunoglobulins: in-depth review of excipients and acute kidney injury risk. Am J Nephrol. 2013;38(4):275-284. doi:10.1159/000354893 [PubMed 24051350]
  47. Daphnis E, Stylianou K, Alexandrakis M, et al. Acute renal failure, translocational hyponatremia and hyperkalemia following intravenous immunoglobulin therapy. Nephron Clin Pract. 2007;106(4):c143-c148. [PubMed 17596722]
  48. Darenberg J, Ihendyane N, Sjölin J, et al; StreptIg Study Group. Intravenous immunoglobulin G therapy in streptococcal toxic shock syndrome: a European randomized, double-blind, placebo-controlled trial. Clin Infect Dis. 2003;37(3):333-340. doi:10.1086/376630 [PubMed 12884156]
  49. Djamali A, Brennan DC. Kidney transplantation in adults: prevention and treatment of antibody-mediated rejection of the renal allograft. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed February 24, 2021.
  50. Drucker NA, Colan SD, Lewis AB, et al, "Gamma-Globulin Treatment of Acute Myocarditis in the Pediatric Population," Circulation, 1994, 89(1):252-7. [PubMed 8281654]
  51. Eichhorst B, Dreyling M, Robak T, Montserrat E, Hallek M; ESMO Guidelines Working Group. Chronic lymphocytic leukemia: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2011;22(suppl 6):vi50-vi54. doi:10.1093/annonc/mdr377 [PubMed 21908504]
  52. Eid AJ, Ardura MI; AST Infectious Diseases Community of Practice. Human parvovirus B19 in solid organ transplantation: guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13535. doi:10.1111/ctr.13535 [PubMed 30973192]
  53. El-Bayoumi MA, El-Refaey AM, Abdelkader AM, El-Assmy MM, Alwakeel AA, El-Tahan HM. Comparison of intravenous immunoglobulin and plasma exchange in treatment of mechanically ventilated children with Guillain Barré syndrome: a randomized study. Crit Care. 2011;15(4):R164. [PubMed 21745374]
  54. Elovaara I, Apostolski S, van Doorn P, et al; EFNS. EFNS guidelines for the use of intravenous immunoglobulin in treatment of neurological diseases: EFNS Task Force on the Use of Intravenous Immunoglobulin in Treatment of Neurological Diseases. Eur J Neurol. 2008;15(9):893-908. [PubMed 18796075]
  55. English RF, Janosky JE, Ettedgui JA, et al, "Outcomes for Children With Acute Myocarditis," Cardiol Young, 2004, 14(5):488-93. [PubMed 15680069]
  56. FDA Safety Communication: updated information on the risks of thrombosis and hemolysis potentially related to administration of intravenous, subcutaneous and intramuscular human immune globulin products. November, 13, 2012. http://wayback.archive-it.org/7993/20170112095655/http:/www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm327934.htm.
  57. Feasby T, Banwell B, Benstead T, et al. Guidelines on the use of intravenous immune globulin for neurologic conditions. Transfus Med Rev. 2007;21(2)(suppl 1):57-107. doi:10.1016/j.tmrv.2007.01.002 [PubMed 17397768]
  58. Flebogamma 5% DIF (immune globulin intravenous [human]) [prescribing information]. Barcelona, Spain: Instituto Grifols, SA; September 2019. [PubMed 23744661]
  59. Flebogamma 10% DIF (immune globulin intravenous [human]) [prescribing information]. Barcelona, Spain: Instituto Grifols; September 2019.
  60. Frickhofen N, Abkowitz JL, Safford M, et al. Persistent B19 parvovirus infection in patients infected with human immunodeficiency virus type 1 (HIV-1): a treatable cause of anemia in AIDS. Ann Intern Med. 1990;113(12):926-933. doi:10.7326/0003-4819-113-12-926 [PubMed 2173460]
  61. Gajdos P, Tranchant C, Clair B, et al; Myasthenia Gravis Clinical Study Group. Treatment of myasthenia gravis exacerbation with intravenous immunoglobulin: a randomized double-blind clinical trial. Arch Neurol. 2005;62(11):1689-1693. doi:10.1001/archneur.62.11.1689 [PubMed 16286541]
  62. Gale RP, Chapel HM, Bunch C, et al; Cooperative Group for the Study of Immunoglobulin in Chronic Lymphocytic Leukemia. Intravenous immunoglobulin for the prevention of infection in chronic lymphocytic leukemia. A randomized, controlled clinical trial. N Engl J Med. 1988;319(14):902-907. doi:10.1056/NEJM198810063191403 [PubMed 2901668]
  63. GamaSTAN (immune globulin intramuscular [human]) [prescribing information]. Research Triangle Park, NC: Grifols Therapeutics Inc; February 2018.
  64. GamaSTAN S/D (immune globulin intramuscular [human]) [product monograph]. Mississauga, Ontario, Canada: Grifols Therapeutics Inc; February 2018.
  65. Gammagard Liquid (immune globulin intravenous and subcutaneous [human]) [prescribing information]. Lexington, MA: Baxalta US Inc; November 2020.
  66. Gammagard S/D (immune globulin intravenous [human]) [prescribing information]. Lexington, MA: Baxalta US Inc; March 2021.
  67. Gammagard S/D (immune globulin intravenous [human]) [product monograph]. Mississauga, Ontario: Baxalta Canada Corporation; December 2016.
  68. Gammaked (immune globulin intravenous and subcutaneous [human]) [prescribing information]. Research Triangle Park, NC: Grifols Therapeutics LLC; January 2020.
  69. Gammaplex 5% (immune globulin intravenous [human]) [prescribing information]. Durham, NC: BPL Inc; September 2019.
  70. Gammaplex 10% (immune globulin intravenous [human]) [prescribing information]. Durham, NC: BPL Inc; October 2019.
  71. Gamunex-C (immune globulin [human]) [prescribing information]. Research Triangle Park, NC: Grifols Therapeutics LLC; January 2020.
  72. Gamunex-C (immune globulin [human]) [prescribing information]. Research Triangle Park, NC: Grifols Therapeutics LLC; June 2018.
  73. Gershon AA, Piomelli S, Karpatkin M, Smithwick E, Steinberg S. Antibody to varicella-zoster virus after passive immunization against chickenpox. J Clin Microbiol. 1978;8(6):733-735. [PubMed 217893]
  74. Girish G, Chawla D, Agarwal R, et al, "Efficacy of Two Dose Regimes of Intravenous Immunoglobulin in Rh Hemolytic Disease of Newborn--a Randomized Controlled Trial," Indian Pediatr, 2008, 45(8):653-9. [PubMed 18723908]
  75. Gorelik M, Chung SA, Ardalan K, et al. 2021 American College of Rheumatology/Vasculitis Foundation guideline for the management of Kawasaki disease. Arthritis Care Res (Hoboken). 2022;74(4):538-548. doi:10.1002/acr.24838 [PubMed 35257507]
  76. Gottlieb F, Deutsch J. Red cell aplasia responsive to immunoglobulin therapy as initial manifestation of human immunodeficiency virus infection. Am J Med. 1992;92(3):331-333. doi:10.1016/0002-9343(92)90085-p [PubMed 1546732]
  77. Gottstein R, Cooke RW. Systematic Review of Intravenous Immunoglobulin in Haemolytic Disease of the Newborn. Arch Dis Child Fetal Neonatal Ed. 2003;88(1):F6-F10. [PubMed 12496219]
  78. Grindeland JW, Grindeland CJ, Moen C, Leedahl ND, Leedahl DD. Outcomes associated with standardized ideal body weight dosing of intravenous immune globulin in hospitalized patients: a multicenter study. Ann Pharmacother. 2020;54(3):205-212. doi:10.1177/1060028019880300 [PubMed 31578070]
  79. Guo Y, Tian X, Wang X, Xiao Z. Adverse effects of immunoglobulin therapy. Front Immunol. 2018;9:1299. doi:10.3389/fimmu.2018.01299 [PubMed 29951056]
  80. Hachem RR, Yusen RD, Meyers BF, et al. Anti-human leukocyte antigen antibodies and preemptive antibody-directed therapy after lung transplantation. J Heart Lung Transplant. 2010;29(9):973-980. doi:10.1016/j.healun.2010.05.006 [PubMed 20558084]
  81. Hahn AF, Bolton CF, Zochodne D, Feasby TE. Intravenous immunoglobulin treatment in chronic inflammatory demyelinating polyneuropathy. A double-blind, placebo-controlled, cross-over study. Brain. 1996;119(pt 4):1067-1077. doi:10.1093/brain/119.4.1067 [PubMed 8813271]
  82. Hallek M, Cheson BD, Catovsky D, et al. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood. 2018;131(25):2745-2760. doi:10.1182/blood-2017-09-806398 [PubMed 29540348]
  83. Henderson LA, Canna SW, Friedman KG, et al. American College of Rheumatology (ACR) clinical guidance for multisystem inflammatory syndrome in children associated with SARS-CoV-2 and hyperinflammation in pediatric COVID-19: Version 3. Arthritis Rheumatol. Published online February 3, 2022. doi:10.1002/art.42062 [PubMed 35118829]
  84. Herzog S, Schmidt E, Goebeler M, Bröcker EB, Zillikens D. Serum levels of autoantibodies to desmoglein 3 in patients with therapy-resistant pemphigus vulgaris successfully treated with adjuvant intravenous immunoglobulins. Acta Derm Venereol. 2004;84(1):48-52. doi:10.1080/00015550310005861 [PubMed 15040478]
  85. HHS Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children. Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children. December 2016. https://aidsinfo.nih.gov/contentfiles/lvguidelines/oi_guidelines_pediatrics.pdf.
  86. Hia CP, Yip WC, Tai BC, et al, "Immunosuppressive Therapy in Acute Myocarditis: An 18 Year Systematic Review," Arch Dis Child, 2004, 89(6):580-4. [PubMed 15155409]
  87. Hizentra (immune globulin) [prescribing information]. Kankakee, IL: CSL Behring LLC; April 2022.
  88. Hizentra (immune globulin) [product monograph]. Ottawa, Ontario, Canada: CSL Behring Canada, Inc; February 2020.
  89. Hodkinson JP. Considerations for dosing immunoglobulin in obese patients. Clin Exp Immunol. 2017;188(3):353-362. doi:10.1111/cei.12955 [PubMed 28263379]
  90. Hodkinson JP, Lucas M, Lee M, Harrison M, Lunn MP, Chapel H. Therapeutic immunoglobulin should be dosed by clinical outcome rather than by body weight in obese patients. Clin Exp Immunol. 2015;181(1):179-187. doi:10.1111/cei.12616 [PubMed 25731216]
  91. Hughes RA, Donofrio P, Bril V, et al; ICE Study Group. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol. 2008;7(2):136-144. doi:10.1016/S1474-4422(07)70329-0 [PubMed 18178525]
  92. HyQvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) [prescribing information]. Lexington, MA: Baxalta US Inc; March 2021.
  93. INIS Collaborative Group, Brocklehurst P, Farrell B, et al, "Treatment of Neonatal Sepsis With Intravenous Immune Globulin," N Engl J Med, 2011, 365(13):1201-11. [PubMed 21962214]
  94. Intravenous immunoglobulin for the prevention of infection in chronic lymphocytic leukemia. A randomized, controlled clinical trial. Cooperative Group for the Study of Immunoglobulin in Chronic Lymphocytic Leukemia (CGSIGCLL). N Engl J Med. 1988;319(14):902-907. [PubMed 2901668]
  95. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
  96. Jenson HB and Pollock BH, "Meta-Analyses of the Effectiveness of Intravenous Immune Globulin for Prevention and Treatment of Neonatal Sepsis," Pediatrics, 1997, 99(2):E2. [PubMed 9099759]
  97. Jordan JA. Treatment and prevention of parvovirus B19 infection. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed June 25, 2021.
  98. Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009;9(suppl 3):S1-S155. doi:10.1111/j.1600-6143.2009.02834.x [PubMed 19845597]
  99. Klugman D, Berger JT, Sable CA, et al, "Pediatric Patients Hospitalized With Myocarditis: A Multi-institutional Analysis," Pediatr Cardiol, 2010, 31(2):222-8. [PubMed 19936586]
  100. Kobayashi T, Kobayashi T, Morikawa A, et al. Efficacy of intravenous immunoglobulin combined with prednisolone following resistance to initial intravenous immunoglobulin treatment of acute Kawasaki disease. J Pediatr. 2013;163(2):521-526. doi:10.1016/j.jpeds.2013.01.022 [PubMed 23485027]
  101. Koduri PR. Parvovirus B19-related anemia in HIV-infected patients. AIDS Patient Care STDS. 2000;14(1):7-11. doi:10.1089/108729100318082 [PubMed 12240888]
  102. Koduri PR, Kumapley R, Valladares J, Teter C. Chronic pure red cell aplasia caused by parvovirus B19 in AIDS: use of intravenous immunoglobulin--a report of eight patients. Am J Hematol. 1999;61(1):16-20. doi:10.1002/(sici)1096-8652(199905)61:1<16::aid-ajh4>3.0.co;2-y [PubMed 10331506]
  103. Koh MJ and Tay YK, "Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in Asian Children," J Am Acad Dermatol, 2010, 62(1):54-60. [PubMed 19811851]
  104. Korinthenberg R, Schessl J, Kirschner J, Mönting JS. Intravenously administered immunoglobulin in the treatment of childhood Guillain-Barré syndrome: a randomized trial. Pediatrics. 2005;116(1):8-14. [PubMed 15995024]
  105. Lachiewicz AM, Srinivas ML. Varicella-zoster virus post-exposure management and prophylaxis: a review. Prev Med Rep. 2019;16:101016. doi:10.1016/j.pmedr.2019.101016 [PubMed 31890472]
  106. Lagasse C, Hatton RC, Pyles E. A survey of intravenous immune globulin (IVIG) dosing strategies. Ann Pharmacother. 2015;49(2):254-257. doi:10.1177/1060028014559095 [PubMed 25583939]
  107. Lange DJ, Robison-Papp J. Multifocal motor neuropathy. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed January 25, 2022.
  108. Leung DY, Kelly CP, Boguniewicz M, et al, "Treatment With Intravenously Administered Gamma Globulin of Chronic Relapsing Colitis Induced by Clostridium difficile Toxin," J Pediatr, 1991, 118(4 Pt 1):633-7. [PubMed 1901084]
  109. Lewis RA, Ashok Muley S. Chronic inflammatory demyelinating polyneuropathy: treatment and prognosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed February 16, 2021.
  110. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  111. Marchioni E, Marinou-Aktipi K, Uggetti C, et al. Effectiveness of intravenous immunoglobulin treatment in adult patients with steroid-resistant monophasic or recurrent acute disseminated encephalomyelitis. J Neurol. 2002;249(1):100-104. doi:10.1007/pl00007836 [PubMed 11954856]
  112. Marin M, Güris D, Chaves SS, Schmid S, Seward JF; Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention (CDC). Prevention of varicella: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2007;56(RR-4):1-40. [PubMed 17585291]
  113. McCrindle BW, Rowley AH, Newburger JW, et al. Diagnosis, treatment, and long-term management of Kawasaki Disease: a scientific statement for health professionals from the American Heart Association. Circulation. 2017;135(17):e927-e999. doi: 10.1161/CIR.0000000000000484. [PubMed 28356445]
  114. McFarland LV, Brandmarker SA, and Guandalini S, "Pediatric Clostridium difficile: A Phantom Menace or Clinical Reality?" J Pediatr Gastroenterol Nutr, 2000, 31(3):220-31. [PubMed 10997362]
  115. McLean HQ, Fiebelkorn AP, Temte JL, Wallace GS; Centers for Disease Control and Prevention. Prevention of measles, rubella, congenital rubella syndrome, and mumps, 2013: summary recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2013;62(RR-04):1-34. [PubMed 23760231]
  116. Mendell JR, Barohn RJ, Freimer ML, et al; Working Group on Peripheral Neuropathy. Randomized controlled trial of IVIg in untreated chronic inflammatory demyelinating polyradiculoneuropathy. Neurology. 2001;56(4):445-449. doi:10.1212/wnl.56.4.445 [PubMed 11222785]
  117. Miqdad AM, Abdelbasit OB, Shaheed MM, et al, "Intravenous Immunoglobulin G (IVIG) Therapy for Significant Hyperbilirubinemia in ABO Hemolytic Disease of the Newborn," J Matern Fetal Neonatal Med, 2004, 16(3):163-6. [PubMed 15590442]
  118. Morici MV, Galen WK, Shetty AK, et al, "Intravenous Immunoglobulin Therapy for Children With Stevens-Johnson Syndrome," J Rheumatol, 2000, 27(10):2494-7. [PubMed 11036849]
  119. Morrison VA. Prevention of infections in patients with chronic lymphocytic leukemia. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed May 25, 2022.
  120. Muchnik S, Losavio AS, Vidal A, Cura L, Mazia C. Long-term follow-up of Lambert-Eaton syndrome treated with intravenous immunoglobulin. Muscle Nerve. 1997;20(6):674-678. doi:10.1002/(sici)1097-4598(199706)20:6<674::aid-mus3>3.0.co;2-5 [PubMed 9149073]
  121. Muley SA. Guillain-Barré syndrome in adults: treatment and prognosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed October 7, 2021.
  122. National Institutes of Health (NIH). COVID-19 Treatment Guidelines Panel. Therapeutic management of hospitalized pediatric patients with multisystem inflammatory syndrome in children (MIS-C) (with discussion on multisystem inflammatory syndrome in adults [MIS-A]). https://www.covid19treatmentguidelines.nih.gov/management/clinical-management/hospitalized-pediatric-patients--therapeutic-management-of-mis-c/. Updated February 24, 2022. Accessed March 7, 2022.
  123. Nelson NP, Weng MK, Hofmeister MG, et al. Prevention of hepatitis A virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices, 2020. MMWR Recomm Rep. 2020;69(5):1-38. [PubMed 32614811]
  124. Neunert C, Lim W, Crowther M, Cohen A, Solberg L Jr, Crowther MA; American Society of Hematology. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood. 2011;117(16):4190-4207. [PubMed 21325604]
  125. Neunert C, Terrell DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019;3(23):3829-3866. doi:10.1182/bloodadvances.2019000966 [PubMed 31794604]
  126. Newburger JW, Takahashi M, Beiser AS, et al. A single intravenous infusion of gamma globulin as compared with four infusions in the treatment of acute Kawasaki syndrome. N Engl J Med. 1991;324(23):1633-1639. doi:10.1056/NEJM199106063242305 [PubMed 1709446]
  127. Nguyen MK, Rastogi A, Kurtz I. True hyponatremia secondary to intravenous immunoglobulin. Clin Exp Nephrol. 2006;10(2):124-126. [PubMed 16791398]
  128. Nguyen TP, Nguyen TD, Zhu L, et al. Precision intravenous immunoglobulin dosing and clinical outcomes: a retrospective chart review. J Clin Neuromuscul Dis. 2021;23(1):18-23. doi:10.1097/CND.0000000000000359 [PubMed 34431797]
  129. NIH Consensus Conference. Intravenous immunoglobulin. Prevention and treatment of disease. JAMA. 1990;264(24):3189-3193. [PubMed 2255028]
  130. Octagam (immune globulin intravenous [human]) [prescribing information]. Hoboken, NJ: Octapharma USA Inc; October 2014.
  131. Octagam 5% (immune globulin intravenous [human]) [prescribing information]. Paramus, NJ: Octapharma USA Inc; April 2022.
  132. Octagam 5% (immune globulin intravenous [human]) [product monograph]. Toronto, Canada: Octapharma Canada Inc; November 2018.
  133. Octagam 10% (immune globulin intravenous [human]) [prescribing information]. Paramus, NJ: Octapharma USA Inc; June 2021.
  134. Octagam 10% (immune globulin intravenous [human]) [product monograph]. Toronto, Ontario, Canada: Octapharma Canada Inc; May 2022.
  135. Ohlsson A and Lacy J, "Intravenous Immunoglobulin for Suspected or Subsequently Proven Infection in Neonates," Cochrane Database Syst Rev, 2010, (3):CD001239. [PubMed 20238315]
  136. Orange JS. Immune globulin therapy in primary immunodeficiency. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed August 17, 2021.
  137. Pacheco LD, Berkowitz RL, Moise KJ Jr, Bussel JB, McFarland JG, Saade GR. Fetal and neonatal alloimmune thrombocytopenia: a management algorithm based on risk stratification. Obstet Gynecol. 2011;118(5):1157-1163. doi:10.1097/AOG.0b013e31823403f4 [PubMed 22015886]
  138. Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646. doi: 10.1155/2012/985646. [PubMed 22235228]
  139. Panzyga (immune globulin intravenous [human] - ifas) [prescribing information]. Paramus, NJ: Octapharma USA Inc; March 2021.
  140. Parks T, Wilson C, Curtis N, Norrby-Teglund A, Sriskandan S. Polyspecific intravenous immunoglobulin in clindamycin-treated patients with streptococcal toxic shock syndrome: a systematic review and meta-analysis. Clin Infect Dis. 2018;67(9):1434-1436. doi:10.1093/cid/ciy401 [PubMed 29788397]
  141. Patwa HS, Chaudhry V, Katzberg H, Rae-Grant AD, So YT. Evidence-based guideline: intravenous immunoglobulin in the treatment of neuromuscular disorders: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2012;78(13):1009-1015. [PubMed 22454268]
  142. Pecoraro A, Ricci S, Vultaggio A, Boggia GM, Spadaro G; SHIFT and IBIS Study Groups. Correlations among subcutaneous immunoglobulin dosage, immunoglobulin G serum pre-infusional levels and body mass index in primary antibody deficiency patients: a pooled analysis from the SHIFT/IBIS studies. Clin Drug Investig. 2020;40(3):279-286. doi:10.1007/s40261-020-00885-8 [PubMed 32036588]
  143. Pentsuk N, van der Laan JW. An interspecies comparison of placental antibody transfer: new insights into developmental toxicity testing of monoclonal antibodies. Birth Defects Res B Dev Reprod Toxicol. 2009;86(4):328-344. doi: 10.1002/bdrb.20201. [PubMed 19626656]
  144. Perez EE, Orange JS, Bonilla F, et al. Update on the use of immunoglobulin in human disease: a review of evidence. J Allergy Clin Immunol. 2017;139(3S):S1-S46. doi:10.1016/j.jaci.2016.09.023 [PubMed 28041678]
  145. Plasma Exchange/Sandoglobulin Guillain-Barré Syndrome Trial Group. Randomised trial of plasma exchange, intravenous immunoglobulin, and combined treatments in Guillain-Barré syndrome. Lancet. 1997;349(9047):225-230. [PubMed 9014908]
  146. Privigen (immune globulin intravenous [human]) [prescribing information]. Kankakee, IL: CSL Behring LLC; March 2022.
  147. Raphael JC, Chevret S, Harboun M, Jars-Guincestre MC; French Guillain-Barré Syndrome Cooperative Group. Intravenous immune globulins in patients with Guillain-Barré syndrome and contraindications to plasma exchange: 3 days versus 6 days. J Neurol Neurosurg Psychiatry. 2001;71(2):235-238. [PubMed 11459901]
  148. Refer to manufacturer's labeling.
  149. Rich MM, Teener JW, Bird SJ. Treatment of Lambert-Eaton syndrome with intravenous immunoglobulin. Muscle Nerve. 1997;20(5):614-615. doi:10.1002/(sici)1097-4598(199705)20:5<614::aid-mus13>3.0.co;2-w [PubMed 9140371]
  150. Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis: Executive summary. Neurology. 2016;87(4):419-425. doi: 10.1212/WNL.0000000000002790. [PubMed 27358333]
  151. Sautenet B, Blancho G, Büchler M, et al. One-year results of the effects of rituximab on acute antibody-mediated rejection in renal transplantation: RITUX ERAH, a multicenter double-blind randomized placebo-controlled trial. Transplantation. 2016;100(2):391-399. doi:10.1097/TP.0000000000000958 [PubMed 26555944]
  152. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
  153. Siegel J. IImmune globulins: therapeutic, pharmaceutical, cost and administration considerations. Pharmacy Practice News. 2011;20-27.
  154. Siegel J. Immunoglobulins and obesity. Pharmacy Practice News. 2010;37:1.
  155. Skeie GO, Apostolski S, Evoli A, et al; European Federation of Neurological Societies. Guidelines for treatment of autoimmune neuromuscular transmission disorders. Eur J Neurol. 2010;17(7):893-902. [PubMed 20402760]
  156. Steinberger BA, Ford SM, Coleman TA. Intravenous immunoglobulin therapy results in post-infusional hyperproteinemia, increased serum viscosity, and pseudohyponatremia. Am J Hematol. 2003;73(2):97-100. [PubMed 12749010]
  157. Stump SE, Schepers AJ, Jones AR, Alexander MD, Auten JJ. Comparison of weight-based dosing strategies for intravenous immunoglobulin in patients with hematologic malignancies. Pharmacotherapy. 2017;37(12):1530-1536. doi:10.1002/phar.2047 [PubMed 29028117]
  158. Sugunan S, Bindusha S, Geetha S, Niyas HR, Kumar AS. Clinical profile and short-term outcome of children with SARS-CoV-2 related multisystem inflammatory syndrome (MIS-C) treated with pulse methylprednisolone. Indian Pediatr. 2021;58(8):718-722. doi:10.1007/s13312-021-2277-4 [PubMed 33876782]
  159. Takemoto SK, Zeevi A, Feng S, et al. National conference to assess antibody-mediated rejection in solid organ transplantation. Am J Transplant. 2004;4(7):1033-1041. doi:10.1111/j.1600-6143.2004.00500.x [PubMed 15196059]
  160. Targoff IN. Treatment of recurrent and resistant dermatomyositis and polymyositis in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed February 18, 2021.
  161. Tomblyn M, Chiller T, Einsele H, et al. Guidelines for preventing infectious complications among hematopoietic cell transplantation recipients: a global perspective. Biol Blood Marrow Transplant. 2009;15(10):1143-1238. doi:10.1016/j.bbmt.2009.06.019 [PubMed 19747629]
  162. Tristani-Firouzi P, Petersen MJ, Saffle JR, et al, "Treatment of Toxic Epidermal Necrolysis With Intravenous Immunoglobulin in Children," J Am Acad Dermatol, 2002, 47(4):548-52. [PubMed 12271299]
  163. van Schaik IN, Bril V, van Geloven N, et al; PATH study group. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2018;17(1):35-46. doi:10.1016/S1474-4422(17)30378-2 [PubMed 29122523]
  164. van Schaik IN, Léger JM, Nobile-Orazio E, et al; Joint task force of the EFNS and the PNS. European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of multifocal motor neuropathy. Report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society--first revision. J Peripher Nerv Syst. 2010;15(4):295-301. doi:10.1111/j.1529-8027.2010.00290.x [PubMed 21199100]
  165. Vleugels RA. Management of refractory cutaneous dermatomyositis in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed May 24, 2022.
  166. Vo AA, Cam V, Toyoda M, Puliyanda DP, et al. Safety and adverse events profiles of intravenous gammaglobulin products used for immunomodulation: a single-center experience. Clin J Am Soc Nephrol. 2006;1(4):844-852. doi:10.2215/CJN.01701105 [PubMed 17699296]
  167. Waldman AT. Acute disseminated encephalomyelitis (ADEM) in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed March 29, 2021.
  168. Walgaard C, Jacobs BC, Lingsma HF, et al; Dutch GBS Study Group. Second intravenous immunoglobulin dose in patients with Guillain-Barré syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2021;20(4):275-283. doi:10.1016/S1474-4422(20)30494-4 [PubMed 33743237]
  169. Wasserman RL. Recombinant human hyaluronidase-facilitated subcutaneous immunoglobulin infusion in primary immunodeficiency diseases. Immunotherapy. 2017;9(12):1035-1050. doi:10.2217/imt-2017-0092 [PubMed 28871852]
  170. Watson JC, Hadler SC, Dykewicz CA, Reef S, Phillips L. Measles, mumps, and rubella--vaccine use and strategies for elimination of measles, rubella, and congenital rubella syndrome and control of mumps: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 1998;47(RR-8):1-57. [PubMed 9639369]
  171. Weinberg DH. Lambert-Eaton myasthenic syndrome: treatment and prognosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed February 22, 2021.
  172. Wimperis J, Lunn M, Jones A, et al, National Health Service. Clinical Guidelines for the Use of Immunoglobulin Use: Second Edition Update, July 2011.
  173. Wingard JR. Prevention of infections in hematopoietic cell transplant recipients. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed June 25, 2021.
  174. Witt CA, Gaut JP, Yusen RD, et al. Acute antibody-mediated rejection after lung transplantation. J Heart Lung Transplant. 2013;32(10):1034-1040. doi:10.1016/j.healun.2013.07.004 [PubMed 23953920]
  175. World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. http://www.who.int/maternal_child_adolescent/documents/55732/en/. Accessed April 17, 2019.
  176. Xembify (immune globulin subcutaneous [human-klhw]) [prescribing information]. Research Triangle Park, NC: Grifols Therapeutics LLC; August 2020.
  177. Zinman L, Ng E, Bril V. IV immunoglobulin in patients with myasthenia gravis: a randomized controlled trial. Neurology. 2007;68(11):837-841. [PubMed 17353471]
Topic 16471 Version 455.0