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Omalizumab

    Brands

    DEA Class; Rx

    Common Brand Names; Xolair

    • Monoclonal Antibodies, Anti-asthmatics

    Monoclonal antibody directed against IgE given by subcutaneous injection
    Used for moderate to severe allergic asthma in adult and pediatric patients 6 years and older, refractory chronic idiopathic urticaria in those 12 years and older, and for nasal polyps in adults with an inadequate response to nasal corticosteroids, as add-on maintenance treatment
    Anaphylactic reactions may develop after the first dose or during ongoing treatment; patients should receive doses in a health care setting and be observed after injections

    Indicated for moderate-to-severe persistent asthma in adults with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms inadequately controlled with inhaled corticosteroids

    Indicated for chronic idiopathic urticaria (CIU) in patients who remain symptomatic despite H1 antihistamine treatment

    Indicated for add-on maintenance treatment of nasal polyps in adults aged ≥18 years with inadequate response to nasal corticosteroids

    Severe hypersensitivity reaction to omalizumab or any of its excipients

    Asthma (aged ≥12 yr)

    • Arthralgia (8%)

    • Pain (7%)

    • Leg pain (4%)

    • Dizziness (3%)

    • Fatigue (3%)

    • Earache (2%)

    • Pruritus (2%)

    • Dermatitis (2%)

    • Arm pain (2%)

    • Fracture (2%)

    CIU

    • Nasopharyngitis (9.1%)

    • Arthralgia (2.9%)

    • Viral upper respiratory tract infection (2.3%)

    • Nausea (1.1%)

    • Cough (1.1%)

    • Sinusitis (1.1%)

    • Upper respiratory tract infection (1.1%)

    Nasal polyps

    • Headache (8.1%)

    • Injection site reactions (5.2%)

    • Upper abdominal pain (3%)

    • Arthralgia (3%)

    • Dizziness (3%)

    Risk of anaphylaxis may occur up to 24 hr after any dose, even if no reaction to the first dose; advise patients to carry emergency self-treatment; discontinue if severe hypersensitivity reaction occurs

    Once therapy has been established, administration by prefilled syringe outside of a healthcare setting by a patient or a caregiver may be appropriate for selected patients; patient selection, determined by healthcare provider in consultation with patient, should take into account the pattern of anaphylaxis events seen in premarketing clinical trials and postmarketing spontaneous reports, as well as individual patient risk factors (eg, prior history of anaphylaxis), ability to recognize signs and symptoms of anaphylaxis, and ability to perform subcutaneous injections with prefilled syringe with proper technique according to prescribed dosing regimen and instructions for use

    Do not discontinue systemic or inhaled corticosteroids abruptly upon initiating omalizumab; decrease corticosteroids gradually over weeks/months; use with corticosteroids has not been evaluated in patients with CIU

    Arthritis/arthralgia, rash, fever, and lymphadenopathy reported

    Malignant neoplasms were observed; malignancy rate was 0.5% compared to 0.2% of controls in clinical trials; a 5-year study found difference in the rates of cancer between omalizumab-treated patients and those who were not treated, but due to limitations of the study, increased cancer risk cannot be ruled out

    Monitor patients at high risk for geohelminth infection while taking omalizumab

    Monitor for eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids

    Not shown to alleviate asthma exacerbations acutely; not for use in acute bronchospasm or status asthmaticus; patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with therapy

    Elevated serum total IgE levels may persist for up to 1 yr following discontinuation; do not use serum total IgE levels obtained <1 year following discontinuation to reassess dosing regimen for asthma or nasal polyps

    Exposure during pregnancy showed no increase in rate of major birth defects or miscarriage;

    Majority of infants (80.9%, 186/230) in pregnancy exposure registry were breastfed; events categorized as “infections and infestations” were not significantly increased in infants who were exposed through breastfeeding compared with infants who were not breastfed, or infants who were breastfed without exposure

    Adults

    For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight, not to exceed 375 mg subcutaneously every 2 weeks.
    For the treatment of chronic idiopathic urticaria: 300 mg subcutaneously every 4 weeks.
    For the treatment of nasal polyps: Dose is determined by baseline serum IgE levels and body weight, not to exceed 600 mg subcutaneously every 2 weeks.

    Geriatric

    For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight, not to exceed 375 mg subcutaneously every 2 weeks.
    For the treatment of chronic idiopathic urticaria: 300 mg subcutaneously every 4 weeks.
    For the treatment of nasal polyps: Dose is determined by baseline serum IgE levels and body weight, not to exceed 600 mg subcutaneously every 2 weeks.

    Adolescents

    For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight, not to exceed 375 mg subcutaneously every 2 weeks.
    For the treatment of chronic idiopathic urticaria: 300 mg subcutaneously every 4 weeks.
    For the treatment of nasal polyps: Safety and efficacy have not been established.

    Children

    12 years:
    For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight, not to exceed 375 mg subcutaneously every 2 weeks.
    For the treatment of chronic idiopathic urticaria: 300 mg subcutaneously every 4 weeks.
    For the treatment of nasal polyps: Safety and efficacy have not been established.
     
    6 to 11 years:
    For the treatment of asthma: Dose is determined by baseline serum IgE levels and body weight.
    6 to 11 years and more than 25 kg: Not to exceed 375 mg subcutaneously every 2 weeks.
    6 to 11 years and 20 to 25 kg: Not to exceed 300 mg subcutaneously every 2 weeks.
    For the treatment of chronic idiopathic urticaria or nasal polyps: Safety and efficacy have not been established.
     
    1 to 5 years: Safety and efficacy have not been established for any indication.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Omalizumab 

    injection, single-dose prefilled syringe

    • 75mg/0.5mL
    • 150mg/mL

    injection, lyophilized powder for reconstitution

    • 150mg/vial
    • 125mg/mL after reconstitution