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Omalizumab: Drug information

Omalizumab: Drug information
(For additional information see "Omalizumab: Patient drug information" and see "Omalizumab: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Anaphylaxis:

Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab. Anaphylaxis has occurred as early as after the first dose of omalizumab but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate omalizumab therapy in a health care setting and closely observe patients for an appropriate period of time after omalizumab administration. Health care providers administering omalizumab should be prepared to manage anaphylaxis, which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care if symptoms occur. Selection of patients for self-administration of omalizumab should be based on criteria to mitigate risk from anaphylaxis.

Brand Names: US
  • Xolair
Brand Names: Canada
  • Xolair
Pharmacologic Category
  • Monoclonal Antibody, Anti-Asthmatic
Dosing: Adult

Note: When treating patients for both asthma and nasal polyps, base dosing on the primary diagnosis for which omalizumab is prescribed. Safety: Due to risk of anaphylaxis, initiate therapy in a health care setting; health care provider will determine if self-administration by the patient or caregiver is appropriate based on risk for anaphylaxis and mitigation strategies.

Asthma, moderate to severe allergic

Asthma, moderate to severe allergic: Note: May consider as add-on therapy in patients with moderate to severe allergic asthma (with a positive skin test or in vitro reactivity to perennial aeroallergen) inadequately controlled with standard therapies (eg, an inhaled glucocorticoid with a long-acting beta agonist) (GINA 2021).

SUBQ: Dose and frequency based on body weight and pretreatment total IgE serum levels (30 to 700 units/mL). Dosing should be adjusted during therapy for significant changes in body weight. Due to elevated IgE levels during therapy, dosing should not be adjusted based on total IgE levels evaluated during treatment or <1 year following interruption of therapy. If therapy has been interrupted for ≥1 year, total IgE levels may be re-evaluated for dosage determination. A minimum of 3 to 6 months of treatment is suggested to determine efficacy (GINA 2021; Wenzel 2022).

Pretreatment serum IgE ≥30 to 100 units/mL:

30 to 90 kg: 150 mg every 4 weeks.

>90 to 150 kg: 300 mg every 4 weeks.

Pretreatment serum IgE >100 to 200 units/mL:

30 to 90 kg: 300 mg every 4 weeks.

>90 to 150 kg: 225 mg every 2 weeks.

Pretreatment serum IgE >200 to 300 units/mL:

30 to 60 kg: 300 mg every 4 weeks.

>60 to 90 kg: 225 mg every 2 weeks.

>90 to 150 kg: 300 mg every 2 weeks.

Pretreatment serum IgE >300 to 400 units/mL:

30 to 70 kg: 225 mg every 2 weeks.

>70 to 90 kg: 300 mg every 2 weeks.

>90 kg: Use not recommended.

Pretreatment serum IgE >400 to 500 units/mL:

30 to 70 kg: 300 mg every 2 weeks.

>70 to 90 kg: 375 mg every 2 weeks.

>90 kg: Use not recommended.

Pretreatment serum IgE >500 to 600 units/mL:

30 to 60 kg: 300 mg every 2 weeks.

>60 to 70 kg: 375 mg every 2 weeks.

>70 kg: Use not recommended.

Pretreatment serum IgE >600 to 700 units/mL:

30 to 60 kg: 375 mg every 2 weeks.

>60 kg: Use not recommended.

Chronic spontaneous urticaria

Chronic spontaneous urticaria: SUBQ: 150 or 300 mg every 4 weeks. Dosing is not dependent on serum IgE (free or total) level or body weight.

Nasal polyps

Nasal polyps: SUBQ: Dose and frequency based on body weight and pretreatment total IgE serum levels. Dosing should be adjusted during therapy for significant changes in body weight. Dosing should not be adjusted based on total IgE levels taken during treatment or <1 year following interruption of therapy. If therapy has been interrupted for ≥1 year, total IgE levels may be reevaluated for dosage determination.

Pretreatment serum IgE ≥30 to 100 units/mL:

30 to 40 kg: 75 mg every 4 weeks.

>40 to 90 kg: 150 mg every 4 weeks.

>90 to 150 kg: 300 mg every 4 weeks.

Pretreatment serum IgE >100 to 200 units/mL:

30 to 40 kg: 150 mg every 4 weeks.

>40 to 90 kg: 300 mg every 4 weeks.

>90 to 125 kg: 450 mg every 4 weeks.

>125 to 150 kg: 600 mg every 4 weeks.

Pretreatment serum IgE >200 to 300 units/mL:

30 to 40 kg: 225 mg every 4 weeks.

>40 to 60 kg: 300 mg every 4 weeks.

>60 to 90 kg: 450 mg every 4 weeks.

>90 to 125 kg: 600 mg every 4 weeks.

>125 to 150 kg: 375 mg every 2 weeks.

Pretreatment serum IgE >300 to 400 units/mL:

30 to 40 kg: 300 mg every 4 weeks.

>40 to 70 kg: 450 mg every 4 weeks.

>70 to 90 kg: 600 mg every 4 weeks.

>90 to 125 kg: 450 mg every 2 weeks.

>125 to 150 kg: 525 mg every 2 weeks.

Pretreatment serum IgE >400 to 500 units/mL:

30 to 50 kg: 450 mg every 4 weeks.

>50 to 70 kg: 600 mg every 4 weeks.

>70 to 90 kg: 375 mg every 2 weeks.

>90 to 125 kg: 525 mg every 2 weeks.

>125 to 150 kg: 600 mg every 2 weeks.

Pretreatment serum IgE >500 to 600 units/mL:

30 to 40 kg: 450 mg every 4 weeks.

>40 to 60 kg: 600 mg every 4 weeks.

>60 to 70 kg: 375 mg every 2 weeks.

>70 to 90 kg: 450 mg every 2 weeks.

>90 to 125 kg: 600 mg every 2 weeks.

>125 kg: Do not administer dose.

Pretreatment serum IgE >600 to 700 units/mL:

30 to 40 kg: 450 mg every 4 weeks.

>40 to 50 kg: 600 mg every 4 weeks.

>50 to 60 kg: 375 mg every 2 weeks.

>60 to 80 kg: 450 mg every 2 weeks.

>80 to 90 kg: 525 mg every 2 weeks.

>90 kg: Do not administer dose.

Pretreatment serum IgE >700 to 800 units/mL:

30 to 40 kg: 300 mg every 2 weeks.

>40 to 50 kg: 375 mg every 2 weeks.

>50 to 70 kg: 450 mg every 2 weeks.

>70 to 80 kg: 525 mg every 2 weeks.

>80 to 90 kg: 600 mg every 2 weeks.

>90 kg: Do not administer dose.

Pretreatment serum IgE >800 to 900 units/mL:

30 to 40 kg: 300 mg every 2 weeks.

>40 to 50 kg: 375 mg every 2 weeks.

>50 to 60 kg: 450 mg every 2 weeks.

>60 to 70 kg: 525 mg every 2 weeks.

>70 to 80 kg: 600 mg every 2 weeks.

>80 kg: Do not administer dose.

Pretreatment serum IgE >900 to 1,000 units/mL:

30 to 40 kg: 375 mg every 2 weeks.

>40 to 50 kg: 450 mg every 2 weeks.

>50 to 60 kg: 525 mg every 2 weeks.

>60 to 70 kg: 600 mg every 2 weeks.

>70 kg: Do not administer dose.

Pretreatment serum IgE >1,000 to 1,100 units/mL:

30 to 40 kg: 375 mg every 2 weeks.

>40 to 50 kg: 450 mg every 2 weeks.

>50 to 60 kg: 600 mg every 2 weeks.

>60 kg: Do not administer dose.

Pretreatment serum IgE >1,100 to 1,200 units/mL:

30 to 40 kg: 450 mg every 2 weeks.

>40 to 50 kg: 525 mg every 2 weeks.

>50 to 60 kg: 600 mg every 2 weeks.

>60 kg: Do not administer dose.

Pretreatment serum IgE >1,200 to 1,300 units/mL:

30 to 40 kg: 450 mg every 2 weeks.

>40 to 50 kg: 525 mg every 2 weeks.

>50 kg: Do not administer dose.

Pretreatment serum IgE >1,300 to 1,500 units/mL:

30 to 40 kg: 525 mg every 2 weeks.

>40 to 50 kg: 600 mg every 2 weeks.

>50 kg: Do not administer dose.

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

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Pediatric

(For additional information see "Omalizumab: Pediatric drug information")

Note: Omalizumab prefilled syringes and reconstituted lyophilized powder are different concentrations; use extra precaution during product selection and during dose volume calculations.

Asthma

Asthma: Dose and frequency based on body weight and pretreatment total IgE serum concentrations. Dosing should be adjusted during therapy for significant changes in body weight. Dosing should not be adjusted based on total IgE concentrations taken during treatment or if there is an interruption of therapy <1 year in duration as total IgE concentrations are elevated during treatment and remain elevated for up to 1 year after discontinuation of treatment. If therapy has been interrupted for ≥1 year, total IgE levels may be reevaluated for dosage determination.

Children ≥6 to <12 years: SUBQ:

Omalizumab Dosing for Patients 6 to <12 Years of Age

Pretreatment serum IgE

Patient weight (kg)

Dose (mg) SUBQ

Frequency (weeks)

≥30 to 100 units/mL

20 to 40 kg

75 mg

every 4 weeks

>40 to 90 kg

150 mg

>90 to 150 kg

300 mg

>100 to 200 units/mL

20 to 40 kg

150 mg

every 4 weeks

>40 to 90 kg

300 mg

>90 to 125 kg

225 mg

every 2 weeks

>125 to 150 kg

300 mg

>200 to 300 units/mL

20 to 30 kg

150 mg

every 4 weeks

>30 to 40 kg

225 mg

>40 to 60 kg

300 mg

>60 to 90 kg

225 mg

every 2 weeks

>90 to 125 kg

300 mg

>125 to 150 kg

375 mg

>300 to 400 units/mL

20 to 30 kg

225 mg

every 4 weeks

>30 to 40 kg

300 mg

>40 to 70 kg

225 mg

every 2 weeks

>70 to 90 kg

300 mg

>90 kg

Do not administer dose.

>400 to 500 units/mL

20 to 25 kg

225 mg

every 4 weeks

>25 to 30 kg

300 mg

>30 to 50 kg

225 mg

every 2 weeks

>50 to 70 kg

300 mg

>70 to 90 kg

375 mg

>90 kg

Do not administer dose.

>500 to 600 units/mL

20 to 30 kg

300 mg

every 4 weeks

>30 to 40 kg

225 mg

every 2 weeks

>40 to 60 kg

300 mg

>60 to 70 kg

375 mg

>70 kg

Do not administer dose.

>600 to 700 units/mL

20 to 25 kg

300 mg

every 4 weeks

>25 to 40 kg

225 mg

every 2 weeks

>40 to 50 kg

300 mg

>50 to 60 kg

375 mg

>60 kg

Do not administer dose.

>700 to 900 units/mL

20 to 30 kg

225 mg

every 2 weeks

>30 to 40 kg

300 mg

>40 to 50 kg

375 mg

>50 kg

Do not administer dose.

>900 to 1,100 units/mL

20 to 25 kg

225 mg

every 2 weeks

>25 to 30 kg

300 mg

>30 to 40 kg

375 mg

>40 kg

Do not administer dose.

>1,100 to 1,200 units/mL

20 to 30 kg

300 mg

every 2 weeks

>30 kg

Do not administer dose.

>1,200 to 1,300 units/mL

20 to 25 kg

300 mg

every 2 weeks

>25 to 30 kg

375 mg

>30 kg

Do not administer dose.

Children ≥12 years and Adolescents: SUBQ:

Omalizumab Dosing for Patients ≥12 Years of Age

Pretreatment serum IgE

Patient weight (kg)

Dose (mg) SUBQ

Frequency (weeks)

≥30 to 100 units/mL

30 to 90 kg

150 mg

every 4 weeks

>90 to 150 kg

300 mg

>100 to 200 units/mL

30 to 90 kg

300 mg

every 4 weeks

>90 to 150 kg

225 mg

every 2 weeks

>200 to 300 units/mL

30 to 60 kg

300 mg

every 4 weeks

>60 to 90 kg

225 mg

every 2 weeks

>90 to 150 kg

300 mg

>300 to 400 units/mL

30 to 70 kg

225 mg

every 2 weeks

>70 to 90 kg

300 mg

>90 kg

Do not administer dose.

>400 to 500 units/mL

30 to 70 kg

300 mg

every 2 weeks

>70 to 90 kg

375 mg

>90 kg

Do not administer dose.

>500 to 600 units/mL

30 to 60 kg

300 mg

every 2 weeks

>60 to 70 kg

375 mg

>70 kg

Do not administer dose.

>600 to 700 units/mL

30 to 60 kg

375 mg

every 2 weeks

>60 kg

Do not administer dose.

Chronic spontaneous urticaria

Chronic spontaneous urticaria: Children ≥12 years and Adolescents: SUBQ: 150 or 300 mg every 4 weeks. Dosing is not dependent on serum IgE (free or total) level or body weight.

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

Dosing adjustment for toxicity:

Children ≥6 years and Adolescents:

Severe hypersensitivity reaction or anaphylaxis: Discontinue treatment.

Fever, arthralgia, and rash: Discontinue treatment if this constellation of symptoms occurs.

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Adjustment for Toxicity: Adult

Severe hypersensitivity reaction or anaphylaxis: Discontinue treatment.

Fever, arthralgia, and rash: Discontinue treatment if this constellation of symptoms occurs.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Xolair: 75 mg/0.5 mL (0.5 mL); 150 mg/mL (1 mL)

Solution Reconstituted, Subcutaneous [preservative free]:

Xolair: 150 mg (1 ea)

Generic Equivalent Available: US

No

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Subcutaneous:

Xolair: 75 mg/0.5 mL (0.5 mL); 150 mg/mL (1 mL)

Solution Reconstituted, Subcutaneous:

Xolair: 150 mg (1 ea)

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103976s5238lbl.pdf#page=36, must be dispensed with this medication.

Administration: Adult

SUBQ: For SUBQ injection only; doses >150 mg should be divided over >1 injection site (eg, 225 or 300 mg administered as 2 injections, 375 or 450 mg administered as 3 injections, 525 or 600 mg administered as 4 injections); each injection site should be separated by ≥1 inch. Administer into clean skin in the abdomen (avoiding areas within 2 inches of navel) and the front and middle of thighs; health care provider/caregiver may also administer in the upper arm. Do not inject into moles, scars, bruises, tender areas, or broken skin. Injections may take 5 to 10 seconds to administer (solution is slightly viscous). Observe patient for 2 hours after the first 3 injections and 30 minutes after subsequent injections (Lieberman 2015) or in accordance with individual institution policies and procedures.

Self-administration (prefilled syringe only): Allow to warm to room temperature for 15 to 30 minutes; leave in carton to protect from light. Do not speed warming process in any way (eg, microwave, warm water). Intended for use under guidance of health care provider. Initiate therapy in a health care setting; health care provider will determine if self-administration by the patient or caregiver is appropriate based on risk for anaphylaxis and mitigation strategies.Candidates for self-administration should be determined following a risk-benefit assessment using the following criteria: Patient has no prior history of anaphylaxis related or unrelated to omalizumab; patient has previously received at least 3 doses of omalizumab; patient/caregiver has the ability to recognize and manage signs/symptoms of a severe hypersensitivity reaction, including anaphylaxis; and patient/caregiver has the ability to perform injections with proper technique and per the prescribed dosing regimen.

Administration: Pediatric

Note: Omalizumab prefilled syringes and reconstituted lyophilized powder are different concentrations; use extra precaution during product selection and during dose volume calculations

Parenteral: SUBQ: Doses >150 mg should be divided into more than 1 injection site (eg, 225 mg or 300 mg administered as 2 injections, 375 mg administered as 3 injections); each injection site should be separated by ≥1 inch; do not inject into moles, scars, bruises, tender areas, or broken skin. Due to viscosity, injection may take 5 to 10 seconds to administer. Administer initial doses and any doses prepared from vials by a health care professional. Observe patient for a minimum of 2 hours after the first 3 injections and 30 minutes after subsequent injections (Lieberman 2015) or in accordance with individual institution policies and procedures.

Lyophilized powder (vial): Recommended injection sites include the upper arm, stomach, or the front and middle of the thighs.

Prefilled syringe: Allow to warm to room temperature for 15 to 30 minutes; leave in carton to protect from light. Do not speed warming process in any way (eg, microwave, warm water). Recommended injection sites include the upper arm and the front and middle of the thighs.

Note : In patients 6 to 11 years of age, doses should be administered by a trained caregiver; patients ≥12 years may self-administer after training. Candidates for self-administration should be determined following a risk-benefit assessment using the following criteria: Patient has no prior history of anaphylaxis related or unrelated to omalizumab; patient has previously received ≥3 doses of omalizumab; patient/caregiver has the ability to recognize and manage signs/symptoms of a severe hypersensitivity reaction, including anaphylaxis; and patient/caregiver has the ability to perform injections with proper technique and per the prescribed dosing regimen.

Use: Labeled Indications

Asthma: Treatment of moderate to severe persistent asthma in adults and patients 6 years and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

Limitations of use: Not indicated for acute bronchospasm or status asthmaticus.

Chronic spontaneous urticaria: Treatment of chronic spontaneous urticaria in adults and adolescents 12 years and older who remain symptomatic despite H1 antihistamine treatment.

Limitations of use: Not indicated for other allergic conditions or other forms of urticaria.

Nasal polyps: Add-on maintenance treatment of nasal polyps in adults with inadequate response to nasal corticosteroids.

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

Omalizumab may be confused with obinutuzumab, ofatumumab

Administration issues:

150 mg vial: After reconstitution, the concentration is 150 mg/1.2 mL; however, the entire vial contains 202.5 mg (which includes overfill). Ensure that the recommended dose is prepared with the overfill remaining in the vial. Dosing errors have been reported in cases where the entire contents of the vial have been withdrawn after reconstitution (ISMP 2019).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidences reported in adolescents and adults unless otherwise noted.

>10%:

Local: Injection site reaction (asthma: 45%, severe 12%; chronic idiopathic urticaria and nasal polyps: 3% to 5%; may include bleeding, bruising, burning, erythema, induration, inflammation, mass, pain, pruritus, stinging, swelling, warmth, urticaria)

Nervous system: Headache (children, adolescents, and adults: 3% to 12%)

1% to 10%:

Cardiovascular: Peripheral edema (≥2%)

Dermatologic: Alopecia (≥2%), dermatitis (2%), pruritus (2%), urticaria (≥2%)

Gastrointestinal: Toothache (≥2%), upper abdominal pain (3%), viral gastroenteritis (children: ≥3%)

Genitourinary: Urinary tract infection (≥2%)

Infection: Fungal infection (≥2%)

Nervous system: Anxiety (≥2%), dizziness (3%), fatigue (3%), migraine (≥2%), pain (7%)

Neuromuscular & skeletal: Arthralgia (3% to 8%), bone fracture (2%), limb pain (2% to 4%), musculoskeletal pain (≥2%), myalgia (≥2%)

Otic: Otalgia (2%), otitis media (children: ≥3%)

Respiratory: Asthma (≥2%), cough (2%), epistaxis (children: ≥3%), nasopharyngitis (children, adolescents, and adults: 3% to 9%), oropharyngeal pain (≥2%), sinus headache (≥2%), sinusitis (5%), streptococcal pharyngitis (children: ≥3%), upper respiratory tract infection (3%), viral upper respiratory tract infection (≤2%)

Miscellaneous: Fever (≥2%)

<1%:

Cardiovascular: Hypotension, syncope

Hematologic & oncologic: Malignant neoplasm

Hypersensitivity: Anaphylaxis, angioedema

Immunologic: Antibody development

Respiratory: Bronchospasm

Frequency not defined: Hematologic & oncologic: Increased serum immunoglobulin (total IgE)

Postmarketing:

Cardiovascular: Eosinophilic granulomatosis with polyangiitis, vasculitis

Dermatologic: Skin rash

Hematologic & oncologic: Decreased serum immunoglobulins (free IgE), eosinophilia, lymphadenopathy, severe thrombocytopenia

Hypersensitivity: Serum sickness

Neuromuscular & skeletal: Arthritis

Contraindications

Severe hypersensitivity reaction to omalizumab or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular effects: Cerebrovascular events, including transient ischemic attack and ischemic stroke, have been reported.

• Eosinophilia and vasculitis: In rare cases, patients may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with eosinophilic granulomatosis with polyangiitis (formerly known as Churg-Strauss), a condition which is often treated with systemic corticosteroid therapy. Health care providers should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between omalizumab and these underlying conditions has not been established.

• Fever/arthralgia/rash: Reports of a constellation of symptoms including fever, arthritis or arthralgia, rash, and lymphadenopathy have been reported with postmarketing use (symptoms resemble those seen in patients experiencing serum sickness, although circulating immune complexes or a skin biopsy consistent with a Type III hypersensitivity reaction were not seen with these cases). Onset of symptoms generally occurred 1 to 5 days following the first or subsequent doses. Discontinue therapy in any patient reporting this constellation of signs/symptoms.

• Hypersensitivity/anaphylactoid reactions: Approximately 60% to 70% of cases reported occur within the first 3 doses; time to onset was within 2 hours for ~75% of cases; however, reactions have been reported with subsequent doses (after 39 doses) and with a time to onset of up to 4 days after administration. A case-control study showed that patients with a history of anaphylaxis to foods, medications, or other causes were at an increased risk of anaphylaxis. An epinephrine autoinjector should be prescribed for all patients receiving omalizumab (Lieberman 2015). Discontinue therapy following any severe reaction.

• Malignant neoplasms: Have been reported rarely with use in short-term studies; impact of long-term use is not known.

Disease-related concerns:

• Asthma: Therapy has not been shown to alleviate acute asthma exacerbations; do not use to treat acute bronchospasm, status asthmaticus, or other allergic conditions.

• Parasitic infections: Use with caution and monitor patients at high risk for parasitic (helminth) infections; risk of infection may be increased; appropriate duration of continued monitoring following therapy discontinuation has not been established.

Concurrent drug therapy issues:

• Corticosteroid therapy: Do not discontinue corticosteroids abruptly following initiation of omalizumab therapy. Reductions in corticosteroid dose should be gradual, if appropriate. Clinicians should note that a reduction in corticosteroid dose may be associated with withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. The combined use of omalizumab and corticosteroids in patients with chronic spontaneous urticaria has not been evaluated.

Dosage form specific issues:

• Latex: Prefilled syringe: The needle cap may contain natural rubber latex.

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

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination

Reproductive Considerations

Data related to the use of monoclonal antibodies for the treatment of asthma in pregnancy is limited. The long half-life of monoclonal antibodies should be considered when prescribing to patients planning to become pregnant (Pfaller 2021).

Pregnancy Considerations

Omalizumab crosses the placenta (Majou 2021; Saito 2020).

Omalizumab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).

Outcome data related to the use of omalizumab in pregnancy are available from case reports of women with severe asthma (Gemicioğlu 2021; Kupryś-Lipińska 2014) or chronic spontaneous urticaria (some also with asthma) (Cuervo-Pardo 2016; Ensina 2017; Ghazanfar 2015; González-Medina 2017). In addition, information from the Xolair Pregnancy Registry (EXPECT) is available. Based on data collected from 250 women between 2006 and 2018, the incidence of major congenital malformations was not increased when compared to pregnant females with asthma not treated with omalizumab. The risk of low birth weight infants was increased; however, more severe asthma in the females taking omalizumab may also have contributed (Namazy 2020).

Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low-birth-weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes). Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]; GINA 2021).

Use of omalizumab in pregnancy may be considered when conventional therapies are insufficient (ERS/TSANZ [Middleton 2020]).

Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) (1-877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.

Breastfeeding Considerations

Omalizumab is present in breast milk (Saito 2020).

Omalizumab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations in breast milk are dependent upon IgG subclass and postpartum age (Anderson 2021).

Based on information from the pregnancy exposure registry, an increased risk of adverse events was not observed in breastfed infants of mothers using omalizumab. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Use of monoclonal antibodies for the treatment of asthma in lactating patients may be considered when conventional therapies are insufficient; omalizumab is considered possibly acceptable in for use in breastfeeding patients (ERS/TSANZ [Middleton 2020]).

Monitoring Parameters

Anaphylactic/hypersensitivity reactions (observe patients for 2 hours after the first 3 injections and 30 minutes after subsequent injections [Lieberman 2015] or in accordance with individual institution policies and procedures); baseline serum total IgE; FEV1, peak flow, and/or other pulmonary function tests; monitor for signs of infection

Mechanism of Action

Asthma and nasal polyps: Omalizumab is an IgG monoclonal antibody (recombinant DNA derived) which inhibits IgE binding to the high-affinity IgE receptor (FcεRI) on mast cells and basophils. By decreasing bound IgE, the activation and release of mediators in the allergic response (early and late phase) is limited. Serum free IgE levels and the number of high-affinity IgE receptors are decreased. Long-term treatment in patients with allergic asthma showed a decrease in asthma exacerbations and corticosteroid usage.

Chronic spontaneous urticaria: Omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of omalizumab result in an improvement of chronic spontaneous urticaria symptoms is unknown.

Pharmacokinetics

Onset of action: Response to therapy: ~12 to 16 weeks (87% of patients had measurable response in 12 weeks).

Absorption: Slow following SUBQ injection.

Distribution: Vd: 78 ± 32 mL/kg.

Metabolism: Degradation of IgG and omalizumab:IgE complexes by reticuloendothelial system and endothelial cells in the liver.

Bioavailability: 62%.

Half-life elimination: 26 days (asthma patients); 24 days (chronic spontaneous urticaria patients).

Time to peak: 7 to 8 days.

Excretion: Primarily via hepatic degradation; intact IgG may be secreted in bile.

Pricing: US

Solution (reconstituted) (Xolair Subcutaneous)

150 mg (per each): $1,465.38

Solution Prefilled Syringe (Xolair Subcutaneous)

75 mg/0.5 mL (per 0.5 mL): $732.68

150 mg/mL (per mL): $1,465.38

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
  • Xolair (AE, AR, AT, AU, BB, BE, BG, BR, CH, CL, CO, CR, CY, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IS, IT, JO, JP, KR, KW, LB, LT, LU, LV, MT, MY, NI, NL, NO, NZ, PA, PE, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, VE)


For country code abbreviations (show table)
  1. Anderson PO. Monoclonal antibodies during breastfeeding. Breastfeed Med. 2021;16(8):591-593. doi:10.1089/bfm.2021.0110 [PubMed 33956488]
  2. Clements T, Rice TF, Vamvakas G, et al. Update on transplacental transfer of IgG subclasses: impact of maternal and fetal factors. Front Immunol. 2020;11:1920. doi:10.3389/fimmu.2020.01920 [PubMed 33013843]
  3. Cuervo-Pardo L, Barcena-Blanch M, Radojicic C. Omalizumab use during pregnancy for CIU: a tertiary care experience. Eur Ann Allergy Clin Immunol. 2016;48(4):145-146. [PubMed 27425170]
  4. Ensina LF, Cusato-Ensina AP, Camelo-Nunes IC, Solé D. Omalizumab as third-line therapy for urticaria during pregnancy. J Investig Allergol Clin Immunol. 2017;27(5):326-327. doi:10.18176/jiaci.0179 [PubMed 29057743]
  5. Gemicioğlu B, Yalçin AD, Havlucu Y, et al. Country-based report: the safety of omalizumab treatment in pregnant patients with asthma. Turk J Med Sci. 2021;51(5):2516-2523. doi:10.3906/sag-2101-341 [PubMed 34174791]
  6. Ghazanfar MN, Thomsen SF. Successful and safe treatment of chronic spontaneous urticaria with omalizumab in a woman during two consecutive pregnancies. Case Rep Med. 2015;2015:368053. doi:10.1155/2015/368053 [PubMed 25705229]
  7. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/wp-content/uploads/2020/04/GINA-2020-full-report_-final-_wms.pdf. Updated 2020. Accessed May 6, 2020.
  8. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. https://ginasthma.org/wp-content/uploads/2021/05/GINA-Main-Report-2021-V2-WMS.pdf. Updated 2021. Accessed December 8, 2021.
  9. González-Medina M, Curto-Barredo L, Labrador-Horrillo M, Giménez-Arnau A. Omalizumab use during pregnancy for chronic spontaneous urticaria (CSU): report of two cases. J Eur Acad Dermatol Venereol. 2017;31(5):e245-e246. doi:10.1111/jdv.14034 [PubMed 27868240]
  10. Institute for Safe Medication Practices (ISMP). ISMP medication safety alert, acute care https://www.ismp.org/newsletters/acute-care. Updated 2019. Accessed September 13, 2019.
  11. Kupryś-Lipińska I, Tworek D, Kuna P. Omalizumab in pregnant women treated due to severe asthma: two case reports of good outcomes of pregnancies. Postepy Dermatol Alergol. 2014;31(2):104-107. doi:10.5114/pdia.2014.40975 [PubMed 25097476]
  12. Lieberman P, Nicklas RA, Randolph C, et al. Anaphylaxis--a practice parameter update 2015. Ann Allergy Asthma Immunol. 2015;115(5):341-384. doi:10.1016/j.anai.2015.07.019 [PubMed 26505932]
  13. Majou D, Moreira B, Martin C, et al. Safety of omalizumab during pregnancy and breast-feeding with assessment of placental transfer: a case report. Allergy Asthma Immunol Res. 2021;13(3):515-516. doi:10.4168/aair.202 [PubMed 33733644]
  14. Middleton PG, Gade EJ, Aguilera C, et al. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J. 2020;55(2):1901208. doi:10.1183/13993003.01208-2019 [PubMed 31699837]
  15. Namazy JA, Blais L, Andrews EB, et al. Pregnancy outcomes in the omalizumab pregnancy registry and a disease-matched comparator cohort. J Allergy Clin Immunol. 2020;145(2):528-536.e1. doi:10.1016/j.jaci.2019.05.019 [PubMed 31145939]
  16. 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]
  17. 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]
  18. Pfaller B, José Yepes-Nuñez J, Agache I, et al. Biologicals in atopic disease in pregnancy: an EAACI position paper. Allergy. 2021;76(1):71-89. doi:10.1111/all.14282 [PubMed 32189356]
  19. Saito J, Yakuwa N, Sandaiji N, et al. Omalizumab concentrations in pregnancy and lactation: a case study. J Allergy Clin Immunol Pract. 2020;8(10):3603-3604. doi:10.1016/j.jaip.2020.05.054 [PubMed 32544544]
  20. Wenzel S. Treatment of severe asthma in adolescents and adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed May 2, 2022.
  21. Xolair (omalizumab) [prescribing information]. South San Francisco, CA: Genentech Inc; July 2021.
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