Prophylaxis of CMV disease in kidney transplant: IV:
Initial dose (within 72 hours of transplant): 150 mg/kg/dose
2-, 4-, 6-, and 8 weeks after transplant: 100 mg/kg/dose
12- and 16 weeks after transplant: 50 mg/kg/dose
Prophylaxis of CMV disease in liver, lung, pancreas, or heart transplant: IV:
Initial dose (within 72 hours of transplant): 150 mg/kg/dose
2-, 4-, 6-, and 8 weeks after transplant: 150 mg/kg/dose
12- and 16 weeks after transplant: 100 mg/kg/dose
Treatment of severe CMV pneumonitis in hematopoietic stem cell transplant (off-label use; in combination with ganciclovir): IV: 400 mg/kg on days 1, 2, and 7, followed by 200 mg/kg on day 14; if still symptomatic, may administer an additional 200 mg/kg on day 21 (Reed, 1988) or 150 mg/kg twice weekly (Alexander, 2010)
There are no dosage adjustments provided in the manufacturer's labeling; use with caution. Infuse at minimum rate possible.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Cytomegalovirus immune globulin: Pediatric drug information")
Solid organ transplantation; prophylaxis: Note: Antiviral medications are recommended for CMV prophylaxis; there is limited data to support the addition of cytomegalovirus immunoglobulin (CMV-Ig) to antiviral medication for prophylaxis. Some centers use both antiviral medications and CMV-Ig for high-risk transplants, such as thoracic or intestinal transplant based on donor and recipient CMV status (Nagai 2016; Transplantation Society International [Kotton 2013])
Heart or lung transplant: Infants, Children, and Adolescents: IV: 150 mg/kg within 72 hours of transplant; 150 mg/kg at weeks 2, 4, 6, and 8 after transplant; 100 mg/kg at weeks 12 and 16 after transplant; specific number of doses and duration may vary among patients and institutional protocols
Kidney transplant: Infants, Children, and Adolescents: Initial: IV: 150 mg/kg within 72 hours of transplant; 100 mg/kg at weeks 2, 4, 6, and 8 after transplant; 50 mg/kg at weeks 12 and 16 after transplant; specific number of doses and duration may vary among patients and institutional protocols
Liver, pancreas, or intestine: Limited data available in small bowel transplantation (Nagai 2016; Transplantation Society International [Kotton 2013]); dosing regimens variable; CMV risk stratification (ie, donor [D] and recipient [R]; CMV status either positive [+] or negative [-]) is suggested (Transplantation Society International [Kotton 2013]):
Low and moderate risk (D-/R-, D-/R+, D+/R+): Limited data available: Infants, Children, and Adolescents: IV: 150 mg/kg once 7 days after transplant (Nagai 2016)
High risk (D+/R-): Infants, Children, and Adolescents:
Fixed bi-weekly dosing: IV: 150 mg/kg within 72 hours of transplant; 150 mg/kg at weeks 2, 4, 6, and 8 after transplant; then 100 mg/kg at weeks 12 and 16 after transplant
Reduced frequency dosing: IV: 150 mg/kg twice weekly for 2 weeks, then weekly for 2 weeks, then every other week for 4 weeks, then monthly for 2 months; if serum CMV IgG negative at that time, continue monthly to 1 year total therapy following transplantation; if CMV IgG positive, discontinue therapy (Nagai 2016)
Treatment, CMV disease: Limited data available (Martin 2011):
Ganciclovir-resistant infection and disease: Infants, Children, and Adolescents: IV: 100 mg/kg/dose weekly in combination with other antivirals (eg, ganciclovir, foscarnet, cidofovir); duration of therapy dependent upon CMV antigenemia assay (pp65) or PCR (Bueno 2002)
Pneumonitis, severe; in combination with ganciclovir: Dosing regimens variable: Children and Adolescents: IV: 400 mg/kg on days 1, 2, and 7 followed by 200 mg/kg on days 14; if still symptomatic, may administer an additional 200 mg/kg on day 21 (Reed 1988); others have used in patients ≥18 years of age a dose of 150 mg/kg twice weekly (Alexander 2010)
Post-solid organ (visceral) transplantation, development of viremia during prophylaxis (detectable CMV polymerase chain reaction [PCR] >250 copies/mL): Infants, Children, and Adolescents: IV: 150 mg/kg every 48 hours for at least 3 doses, then continue to taper by reducing dosing frequency similar to prophylaxis schedule (eg, doses administered twice weekly, followed by weekly, every other week, then monthly; monitor CMV PCR weekly until criteria met [eg, two results are undetectable]); used in combination with antiviral medications (eg, ganciclovir, valganciclovir, foscarnet, cidofovir) (Nagai 2016)
Infantile autoimmune hemolytic anemia, CMV-associated: Very limited data available: Infants: IV: 500 mg/kg CMV Ig followed by 3 days of standard IV immune globulin (IVIG); dosing based on case reports in a 4 month old and an 11 month old who failed to respond to corticosteroids and PRBC transfusions (Murray 2001)
There are no dosage adjustments provided in manufacturer’s labeling; use with caution. Infuse at minimum rate possible.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injectable, Intravenous [preservative free]:
Cytogam: 50 mg/mL (50 mL) [contains albumin human]
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injectable, Intravenous:
Cytogam: 50 mg/mL (50 mL) [contains albumin human]
IV: Administer through an IV line containing an in-line 15 micron filter (a 0.2 micron filter is also acceptable) using an infusion pump. The solution must be free of particulate matter and colorless. Do not mix with other infusions; do not use if turbid. Begin infusion within 6 hours of entering vial, complete infusion within 12 hours of vial entry.
Initial dose: Infuse at 15 mg/kg/hour. If no adverse reactions occur within 30 minutes, may increase rate to 30 mg/kg/hour. If no adverse reactions occur within the second 30 minutes, may increase rate to 60 mg/kg/hour; maximum rate of infusion: 75 mL/hour. Monitor closely after each rate change. If patient develops nausea, back pain, or flushing during infusion, slow the rate or temporarily stop the infusion. Discontinue if blood pressure drops or in case of anaphylactic reaction.
Subsequent doses: Infuse at 15 mg/kg/hour for 15 minutes; if no adverse reactions occur, may increase rate to 30 mg/kg/hour for 15 minutes; if no adverse reactions occur, may increase rate to 60 mg/kg/hour; maximum rate of infusion: 75 mL/hour.
Parenteral: IV infusion: Does not require further dilution; administer as a 50 mg/mL solution through a dedicated IV line containing an in-line 15 micron filter (a 0.2 micron filter is also acceptable) using an infusion pump. Do not mix with other infusions; do not use if turbid; do not shake solution. Begin infusion within 6 hours of entering vial, complete infusion within 12 hours of vial entry. Infusion with other products is not recommended; however, if unavoidable, may be piggybacked into an IV line of NS, D5W, D10W, or dextrose 20% in water; however, do not dilute more than 1:2.
Initial infusion: Begin at 15 mg/kg/hour; if there are no infusion-related reactions after 30 minutes, increase to 30 mg/kg/hour; if no infusion-related reactions after 30 minutes, may increase to 60 mg/kg/hour for the remainder of the infusion; infusion rate should not exceed 75 mL/hour. Monitor closely during and after each rate change. If patient develops nausea, back pain, or flushing during infusion, slow the rate or temporarily stop the infusion. Discontinue if blood pressure drops or in case of anaphylactic reaction.
Subsequent infusions: Initiate at 15 mg/kg/hour for the first 15 minutes, if no infusion-related reactions, increase to 30 mg/kg/hour for the next 15 minutes; if rate is tolerated, increase to 60 mg/kg/hour and maintain this rate until completion of dose; maximum infusion rate: 60 mg/kg/hour or not to exceed 75 mL/hour.
Prophylaxis of cytomegalovirus (CMV) disease associated with kidney, lung, liver, pancreas, and heart transplants; concomitant use with ganciclovir should be considered in organ transplants (other than kidney) from CMV seropositive donors to CMV seronegative recipients
Cytomegalovirus (CMV) pneumonitis in solid organ transplant (adjunctive therapy); Cytomegalovirus (CMV) pneumonitis in hematopoietic stem cell transplant (HSCT) (adjunctive therapy)
CytoGam may be confused with Cytoxan, Gamimune N
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined.
<6%:
Cardiovascular: Flushing
Central nervous system: Chills
Gastrointestinal: Nausea, vomiting
Neuromuscular & skeletal: Arthralgia, back pain, muscle cramps
Respiratory: Wheezing
Miscellaneous: Fever
<1%, postmarketing and/or case reports: Abdominal pain, acute renal failure, acute respiratory distress, anaphylactic shock, angioedema, anuria, apnea, aseptic meningitis, bronchospasm, bullous dermatitis, circulatory shock, coma, cyanosis, decreased blood pressure, dyspnea, epidermolysis, erythema multiforme, hemolysis, hepatic insufficiency, hypersensitivity reaction (systemic), hypotension, hypoxemia, increased blood urea nitrogen, increased serum creatinine, leukopenia, loss of consciousness, oliguria, osmotic nephrosis, pancytopenia, positive direct Coombs test, proximal tubular nephropathy, pulmonary edema, renal insufficiency, renal tubular necrosis, rigors, seizure, Stevens-Johnson syndrome, thromboembolism, transfusion-related acute lung injury, tremor
Hypersensitivity to cytomegalovirus immune globulin (CMV-IGIV), other immunoglobulin preparations, or any component of the formulation; selective immunoglobulin A deficiency
Concerns related to adverse effects:
• Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions can occur; monitor vital signs during infusion; discontinue immediately for hypotension or anaphylaxis; immediate treatment (including epinephrine 1 mg/mL) should be available. Systemic allergic reactions are rare; may be treated with epinephrine and diphenhydramine.
• Aseptic meningitis: Aseptic meningitis syndrome (AMS) has been reported with intravenous immune globulin administration (rare); may occur with high doses (≥2 g/kg). Symptoms include severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements and nausea and vomiting. Syndrome usually appears within several hours to 2 days following treatment; usually resolves within several days after discontinuation.
• Hemolysis: Intravenous immune globulin has been associated with antiglobulin hemolysis; monitor for signs of hemolytic anemia.
• Pulmonary edema: Monitor for adverse pulmonary events including transfusion-related acute lung injury (TRALI); noncardiogenic pulmonary edema has been reported with intravenous immune globulin use. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, and fever in the presence of normal left ventricular function and usually occurs within 1-6 hours after infusion; may be managed with oxygen and respiratory support.
• Renal impairment: Acute renal dysfunction (increased serum creatinine, oliguria, osmotic nephrosis, acute renal failure) can rarely occur; usually within 7 days of use (more likely with products stabilized with sucrose). Patients at risk for renal failure include the elderly, patients with preexisting renal disease, diabetes mellitus, volume depletion, sepsis, paraproteinemia, and nephrotoxic medications. In patients at risk of renal dysfunction, the rate of infusion and concentration of solution should be minimized. Discontinue if renal function deteriorates.
• Thrombotic events: Thrombotic events have been reported with administration of intravenous immune globulin; patients at risk include those with advanced age or a history of atherosclerosis, cardiovascular and/or thrombotic risk factors, or known/suspected hyperviscosity. Consider a baseline assessment of blood viscosity in patients at risk for hyperviscosity.
Disease-related concerns:
• Hypovolemia: Patients should not be volume depleted prior to therapy.
Special populations:
• Older adult: Use with caution in patients >65 years of age.
Dosage form specific issues:
• Albumin: Product is stabilized with albumin.
• Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease. 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.
• Sucrose: Product is stabilized with sucrose.
None known.
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
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
Animal reproduction studies have not been conducted.
May contain sodium.
Renal function (BUN, serum creatinine prior to initial infusion and periodically thereafter); urine output; vital signs, including blood pressure (throughout infusion); signs/symptoms of infusion-related adverse reactions, anaphylaxis; signs and symptoms of hemolytic anemia; blood viscosity (baseline; in patients at risk for hyperviscosity); presence of antineutrophil antibodies (if TRALI is suspected); volume status; weight gain, clinical response
CMV-IGIV is a preparation of immunoglobulin G (and trace amounts of IgA and IgM) derived from pooled healthy blood donors and contains a high titer of CMV antibodies; administration provides a passive source of antibodies against cytomegalovirus to attenuate or reduce the incidence of serious CMV disease
Half-life elimination: 8 to 24 days
Injection (Cytogam Intravenous)
50 mg/mL (per mL): $42.16
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