PDR MEMBER LOGIN:
  • PDR Search

    Required field
  • Advertisement
  • CLASSES

    Immunoglobulin E (IgE) Inhibitors
    Immunotherapies for Reactive and Obstructive Airway Diseases

    DEA CLASS

    Rx

    DESCRIPTION

    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

    COMMON BRAND NAMES

    Xolair, Xolair Prefilled

    HOW SUPPLIED

    Xolair Subcutaneous Inj Pwd F/Sol: 202.5mg
    Xolair Subcutaneous Inj: 0.5mL, 1mL, 75mg, 150mg

    DOSAGE & INDICATIONS

    For asthma maintenance add-on therapy for moderate to severe persistent asthma.
    For baseline serum IgE 30 to 100 International Units/mL.
    Subcutaneous dosage
    Adults weighing 91 to 150 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children and Adolescents 6 to 17 years weighing 91 to 150 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 30 to 90 kg

    150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

    Children and Adolescents 12 to 17 years weighing 30 to 90 kg

    150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 41 to 90 kg

    150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 20 to 40 kg

    75 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

    For baseline serum IgE 101 to 200 International Units/mL.
    Subcutaneous dosage
    Adults weighing 91 to 150 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children and Adolescents 12 to 17 years weighing 91 to 150 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 30 to 90 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children and Adolescents 12 to 17 years weighing 30 to 90 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 126 to 150 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 91 to 125 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 41 to 90 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 20 to 40 kg

    150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

    For baseline serum IgE 201 to 300 International Units/mL.
    Subcutaneous dosage
    Adults weighing 91 to 150 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children and Adolescents 12 to 17 years weighing 91 to 150 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 61 to 90 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children and Adolescents 12 to 17 years weighing 61 to 90 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 30 to 60 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children and Adolescents 12 to 17 years weighing 30 to 60 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 126 to 150 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 91 to 125 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 61 to 90 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 41 to 60 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 31 to 40 kg

    225 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 20 to 30 kg

    150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

    For baseline serum IgE 301 to 400 International Units/mL.
    Subcutaneous dosage
    Adults weighing 71 to 90 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children and Adolescents 12 to 17 years weighing 71 to 90 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 30 to 70 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children and Adolescents 12 to 17 years weighing 30 to 70 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 71 to 90 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 41 to 70 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 31 to 40 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 20 to 30 kg

    225 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 401 to 500 International Units/mL.
    Subcutaneous dosage
    Adults weighing 71 to 90 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children and Adolescents 12 to 17 years weighing 71 to 90 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 30 to 70 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children and Adolescents 12 to 17 years weighing 30 to 70 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 71 to 90 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 51 to 70 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 31 to 50 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 26 to 30 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 20 to 25 kg

    225 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 501 to 600 International Units/mL.
    Subcutaneous dosage
    Adults weighing 61 to 70 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children and Adolescents 12 to 17 years weighing 61 to 70 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 30 to 60 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children and Adolescents 12 to 17 years weighing 30 to 60 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 61 to 70 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 41 to 60 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 31 to 40 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 20 to 30 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 601 to 700 International Units/mL.
    Subcutaneous dosage
    Adults weighing 30 to 60 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children and Adolescents 12 to 17 years weighing 30 to 60 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 51 to 60 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 41 to 50 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 26 to 40 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 20 to 25 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 701 to 900 International Units/mL.
    Subcutaneous dosage
    Children 6 to 11 years weighing 41 to 50 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 31 to 40 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 20 to 30 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 901 to 1,100 International Units/mL.
    Subcutaneous dosage
    Children 6 to 11 years weighing 31 to 40 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 26 to 30 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 20 to 25 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 1,101 to 1,200 International Units/mL.
    Subcutaneous dosage
    Children 6 to 11 years weighing 20 to 30 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 1,201 to 1,300 International Units/mL.
    Subcutaneous dosage
    Children 6 to 11 years weighing 26 to 30 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Children 6 to 11 years weighing 20 to 25 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For the treatment of chronic idiopathic urticaria in patients who remain symptomatic despite H1 antihistamine treatment.
    Subcutaneous dosage
    Adults

    150 mg or 300 mg subcutaneously every 4 weeks. Dosing is independent of serum IgE and body weight. Periodically reassess the need for continued treatment; optimal treatment duration has not been determined. In clinical trials, a larger proportion of patients treated with 300 mg every 4 weeks reported no itching or hives after 12 weeks of treatment compared to those treated with 150 mg every 4 weeks (36% vs. 15%).

    Children and Adolescents 12 years and older

    150 mg or 300 mg subcutaneously every 4 weeks. Dosing is independent of serum IgE and body weight. Periodically reassess the need for continued treatment; optimal treatment duration has not been determined. In clinical trials, a larger proportion of patients treated with 300 mg every 4 weeks reported no itching or hives after 12 weeks of treatment compared to those treated with 150 mg every 4 weeks (36% vs. 15%).

    For the add-on maintenance treatment of nasal polyps in adults with inadequate response to nasal corticosteroids.
    NOTE: For adults with both asthma and nasal polyps, determine dosing based on the primary diagnosis for which omalizumab is being prescribed.
    For baseline serum IgE 30 to 100 International Units/mL.
    Subcutaneous dosage
    Adults weighing 91 to 150 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 41 to 90 kg

    150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

    Adults weighing 31 to 40 kg

    75 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

    For baseline serum IgE 101 to 200 International Units/mL.
    Subcutaneous dosage
    Adults weighing 126 to 150 kg

    600 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 91 to 125 kg

    450 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 41 to 90 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 31 to 40 kg

    150 mg subcutaneously every 4 weeks. Adjust doses for significant changes in body weight.

    For baseline serum IgE 201 to 300 International Units/mL.
    Subcutaneous dosage
    Adults weighing 126 to 150 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 91 to 125 kg

    600 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 61 to 90 kg

    450 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 41 to 60 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 31 to 40 kg

    225 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 301 to 400 International Units/mL.
    Subcutaneous dosage
    Adults weighing 126 to 150 kg

    525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 91 to 125 kg

    450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 71 to 90 kg

    600 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 41 to 70 kg

    450 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 31 to 40 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 401 to 500 International Units/mL.
    Subcutaneous dosage
    Adults weighing 126 to 150 kg

    600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 91 to 125 kg

    525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 71 to 90 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 51 to 70 kg

    600 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 31 to 50 kg

    450 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 501 to 600 International Units/mL.
    Subcutaneous dosage
    Adults weighing more than 125 kg

    A dosage cannot be recommended due to insufficient data in this weight group.

    Adults weighing 91 to 125 kg

    600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 71 to 90 kg

    450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 61 to 70 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site.Adjust doses for significant changes in body weight.

    Adults weighing 41 to 60 kg

    600 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 31 to 40 kg

    450 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 601 to 700 International Units/mL.
    Subcutaneous dosage
    Adults weighing more than 90 kg

    A dosage cannot be recommended due to insufficient data in this weight group.

    Adults weighing 81 to 90 kg

    525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 61 to 80 kg

    450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 51 to 60 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 41 to 50 kg

    600 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 31 to 40 kg

    450 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 701 to 800 International Units/mL.
    Subcutaneous dosage
    Adults weighing more than 90 kg

    A dosage cannot be recommended due to insufficient data in this weight group.

    Adults weighing 81 to 90 kg

    600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 71 to 80 kg

    525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 51 to 70 kg

    450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 41 to 50 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 31 to 40 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 801 to 900 International Units/mL.
    Subcutaneous dosage
    Adults weighing more than 80 kg

    A dosage cannot be recommended due to insufficient data in this weight group.

    Adults weighing 71 to 80 kg

    600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 61 to 70 kg

    525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 51 to 60 kg

    450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 41 to 50 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 31 to 40 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 901 to 1,000 International Units/mL.
    Subcutaneous dosage
    Adults weighing more than 70 kg

    A dosage cannot be recommended due to insufficient data in this weight group.

    Adults weighing 61 to 70 kg

    600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 51 to 60 kg

    525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 41 to 50 kg

    450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site.Adjust doses for significant changes in body weight.

    Adults weighing 31 to 40 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 1,001 to 1,100 International Units/mL.
    Subcutaneous dosage
    Adults weighing more than 60 kg

    A dosage cannot be recommended due to insufficient data in this weight group.

    Adults weighing 51 to 60 kg

    600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 41 to 50 kg

    450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 31 to 40 kg

    375 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 1,101 to 1,200 International Units/mL.
    Subcutaneous dosage
    Adults weighing more than 60 kg

    A dosage cannot be recommended due to insufficient data in this weight group.

    Adults weighing 51 to 60 kg

    600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 41 to 50 kg

    525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 31 to 40 kg

    450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 1,201 to 1,300 International Units/mL.
    Subcutaneous dosage
    Adults weighing more than 50 kg

    A dosage cannot be recommended due to insufficient data in this weight group.

    Adults weighing 41 to 50 kg

    525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 31 to 40 kg

    450 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    For baseline serum IgE 1,301 to 1,500 International Units/mL.
    Subcutaneous dosage
    Adults weighing more than 50 kg

    A dosage cannot be recommended due to insufficient data in this weight group.

    Adults weighing 41 to 50 kg

    600 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    Adults weighing 31 to 40 kg

    525 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Adjust doses for significant changes in body weight.

    MAXIMUM DOSAGE

    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.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Injectable Administration

    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
    Omalizumab is administered by subcutaneous injection only.

    Subcutaneous Administration

    A health care professional should initiate omalizumab treatment in a health care setting that is equipped and prepared to identify and treat anaphylaxis until therapy has been safely established. Selection of patients for self-administration should be based on careful assessment of risk for anaphylaxis and mitigation strategies. The following patient specific criteria should be considered:[44070] [65315]
    No prior history of anaphylaxis, including omalizumab or other agents, such as foods, drugs, biologics, etc.
    Receipt of at least 3 doses of omalizumab under the supervision of a health care provider with no hypersensitivity reactions
    Patient or caregiver is able to recognize symptoms of a severe hypersensitivity reaction (including anaphylaxis) and treat it appropriately
    Patient or caregiver is able to perform subcutaneous injections with the omalizumab prefilled syringe with proper technique
    Patients 12 years of age and older may self-administer under adult supervision
    Observe the patient for an appropriate time after each injection (e.g., up to 120 minutes).
    Instruct the patient to get immediate medical care if signs or symptoms of anaphylaxis or angioedema develop.[44070]
     
    Prefilled Syringe Administration
    Available for use in a prefilled syringe. Omalizumab prefilled syringes are available in 2 dose strengths:
    Omalizumab 75 mg prefilled syringe comes with a blue needle shield.
    Omalizumab 150 mg prefilled syringe with a purple needle shield.
    The prefilled syringe solution should be clear and colorless to pale brownish yellow.
    At least 15 to 30 minutes prior to injection, allow the carton containing the syringe to warm up to room temperature. Keep in the carton to protect it from light. Do not allow the syringe to become hot. Do not speed up the warming process by putting the syringe in the microwave or in warm water.
    Do not open the sealed outer carton until ready to inject. Peel off the blister pack cover. Take the syringe out of the blister pack by holding the middle part of the syringe; do not handle by the needle cap or plunger. Do not take the syringe apart at any time.
    Inspect the syringe closely. The liquid in the syringe should be clear to slightly opalescent and colorless to pale brownish-yellow. Do not use the syringe if the syringe is damaged or expired, or if the liquid is cloudy, discolored, or contains foreign particles.
    Choose an injection site.
    The recommended injection sites are the thigh or abdomen, avoiding the 2-inch area directly around the navel. The outer area of the upper arm may be used only if the injection is given by a caregiver or health care provider.
    Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin.
    Choose a different injection site for each new injection at least 1 inch from the area used for the last injection.
    Each subcutaneous injection should not exceed 150 mg per site; doses of more than 150 mg should be divided among 2 or more injection sites.
    Wipe the injection site with an alcohol pad in a circular motion and let it air dry for 10 seconds.
    Hold the syringe firmly with 1 hand and pull the needle cap straight off with your other hand. There may be a small air bubble in the syringe. This is normal; do not try to remove the air bubble. You may also see a drop of liquid at the end of the needle. This is also normal and will not affect the dose.
    Use your other hand and gently pinch the area of skin that was cleaned. Use a quick, dart-like motion to insert the needle all the way into the pinched skin at an angle between 45 degrees to 90 degrees. Do not insert the needle through clothing.
    Once the needle is inserted, slowly inject all the medicine by gently pushing the plunger all the way down to ensure that the full dose gets injected. It may take 5 to 10 seconds to inject the dose, due to the somewhat viscous nature of the solution.
    Gently release the plunger and allow the needle to be covered by the needle-shield.
    Do not rub the injection site; may cover with a small bandage if needed.
    Disposal: The prefilled syringe is a single-dose syringe and should not be used again. Dispose in an FDA-cleared sharps disposal container right away after use.[44070]
     
    Reconstitution of Lyophilized powder vial
    Determine the number of vials that will be needed for the patient's dose.
    Reconstitute each 150-mg vial by injecting 1.4 mL of Sterile Water for Injection into the vial of omalizumab; reconstitution with 0.9% Sodium Chloride injection is NOT recommended due to noted incompatibility.[63020]
    Keeping the vial upright, gently swirl for approximately 1 minute to evenly wet the powder. Do NOT shake.
    Allow the vial to stand, and gently swirl the vial for 5 to 10 seconds approximately every 5 minutes to dissolve any remaining solids. Some vials may take longer than 20 minutes to dissolve completely. Do not use if the contents of the vial do not completely dissolve in 40 minutes.
    The reconstituted solution should be clear or slightly opalescent and may have a few small bubbles or foam around the edge of the vial; there should be no visible gel-like or foreign particles in the solution.
    The concentration of the reconstituted solution is 150 mg/1.2 mL (i.e., 125 mg/mL).
    Storage: The reconstituted solution in the vial should be used within 8 hours of reconstitution when stored in the refrigerator (2 to 8 degrees C or 36 to 46 degrees F) or within 4 hours when stored at room temperature. Protect from direct sunlight.[44070]
     Preparing the dose from the vial
    Invert the vial to allow the solution to drain toward the stopper. Using a new 3 mL syringe equipped with a 1-inch, 18-gauge needle, insert the needle into the inverted vial. Position the needle tip at the very bottom of the solution in the vial stopper when drawing the solution into the syringe. The reconstituted product is somewhat viscous. Withdraw all the product from the vial before expelling any air or excess solution from the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all the solution from the inverted vial.
    Once the solution is in the syringe, replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
    Expel air, large bubbles, and any excess solution in order to obtain a volume of 1.2 mL corresponding to 150 mg dose. To obtain a volume of 0.6 mL (a dose of 75 mg), expel air, large bubbles and discard 0.6 mL from the syringe. A thin layer of small bubbles may remain at the top of the solution in the syringe.
     Subcutaneous Administration of reconstituted solution:
    Choose and clean an injection site.
    The recommended injection sites are the upper arm and the front and middle of the thighs.
    Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin.
    Choose a different injection site for each new injection at least 1 inch from the area used for the last injection.
    Each subcutaneous injection should not exceed 150 mg per site; doses of more than 150 mg should be divided among 2 or more injection sites.
    Wipe the injection site with an alcohol pad in a circular motion and let it air dry for 10 seconds.
    Inject subcutaneously. The subcutaneous injection may take 5 to 10 seconds to administer due to the viscous solution.
    Dispose used needles and syringes in a FDA-cleared sharps disposal container right away after use.[44070]

    STORAGE

    Xolair:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Protect from direct sunlight
    - Reconstituted product should be used within 8 hours if stored under refrigeration (36 to 46 degrees F) or within 4 hours if stored at room temperature
    - Refrigerate (between 36 and 46 degrees F)
    - See package insert for detailed storage information
    - Store in original container
    - Store reconstituted product in accordance with package insert instructions
    Xolair Prefilled:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Do not use if product has been frozen
    - Protect from direct sunlight
    - Refrigerate (between 36 and 46 degrees F)
    - See package insert for detailed storage information
    - Store in original container

    CONTRAINDICATIONS / PRECAUTIONS

    Hamster protein hypersensitivity, history of angioedema, omalizumab hypersensitivity, requires a specialized care setting, serious hypersensitivity reactions or anaphylaxis

    Omalizumab administration has a risk of serious hypersensitivity reactions or anaphylaxis, and omalizumab hypersensitivity may occur after any dose of omalizumab. Omalizumab is derived from Chinese hamster ovarian cells and may be inappropriate for use by patients with known hamster protein hypersensitivity. Omalizumab is contraindicated for use by patients who have experienced a severe omalizumab hypersensitivity reaction, including anaphylaxis or a history of angioedema with the drug. The initiation of omalizumab therapy requires a specialized care setting that is equipped and prepared to manage serious hypersensitivity reactions, including anaphylaxis that can be life-threatening. The selection of patients for self-administration should be based on criteria to mitigate risk from anaphylaxis. Select patients with no prior history of anaphylaxis related or unrelated to omalizumab, who have received at least 3 doses of omalizumab, have the ability to recognize and manage signs and symptoms of a severe hypersensitivity reaction (including anaphylaxis), and can perform injections with proper technique and per the prescribed dosing regimen.[44070] [65315] Anaphylaxis has occurred after the first omalizumab dose but also has been reported after 1 year of regularly administered treatment. Approximately 60% to 70% of anaphylaxis cases occur within the first 3 doses of omalizumab, with additional cases occurring sporadically after the third dose. Documented signs and symptoms have included bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue. Closely observe patients for an appropriate period of time after each injection of omalizumab, taking into account the noted time to onset of anaphylaxis seen during clinical trials and postmarketing spontaneous reports. While anaphylaxis has most commonly occurred within 1 hour of injection, some cases have been reported up to 120 minutes after a dose, and some anaphylactic reactions have been delayed. Anaphylaxis was reported in 0.1% of patients during clinical asthma trials with omalizumab. In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to omalizumab use was estimated to be at least 0.2% based on an estimated exposure of about 57,300 patients from June 2003 through December 2006. A case-control study showed that omalizumab-treated patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis from omalizumab compared to patients with no prior history of anaphylaxis. Instruct patients on the signs and symptoms of anaphylaxis, including the potential for a delayed reaction to the drug, and to seek immediate medical care should symptoms occur. Discontinue omalizumab treatment in any patient who develops a severe hypersensitivity reaction.[44070]

    Acute bronchospasm, corticosteroid therapy, status asthmaticus

    Omalizumab does not alleviate acute asthma exacerbations acutely and should not be used for the treatment of acute bronchospasm or status asthmaticus. Do not abruptly discontinue systemic or inhaled corticosteroid therapy upon initiation of omalizumab therapy for asthma. Decreases in corticosteroid therapy during omalizumab treatment should be performed under the direct supervision of a prescriber and may need to be performed gradually. During omalizumab therapy, patients receiving omalizumab should be told not to decrease the dose of, or stop taking, any other medications for their condition unless otherwise instructed by their prescriber. If asthma remains uncontrolled or worsens after initiation of treatment with omalizumab, patients should seek medical advice.

    Corticosteroid withdrawal, vasculitis

    Caution is advised when oral corticosteroid withdrawal or a reduction in corticosteroid dose is being considered in patients taking omalizumab. In rare cases, patients with asthma on therapy with omalizumab may present with serious systemic eosinophilia sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction of systemic (oral) corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitis or vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or peripheral neuropathy presenting in their patients. A causal association between omalizumab and these underlying conditions has not been established.

    Arthralgia, fever

    In postmarketing use, some patients have experienced a constellation of signs and symptoms including arthritis and/or arthralgia, rash, fever, and lymphadenopathy with an onset 1 to 5 days after the first or subsequent injections of omalizumab. These signs and symptoms have recurred after additional doses in some patients. Although circulating immune complexes or a skin biopsy consistent with a Type III reaction were not seen with these cases, these signs and symptoms are similar to those seen in patients with serum sickness. Physicians should stop omalizumab treatment if a patient develops this constellation of signs and symptoms.

    Neoplastic disease, new primary malignancy

    Use omalizumab cautiously in patients with a history of neoplastic disease. In clinical trials of adults and adolescents 12 years of age and older with asthma or other allergic conditions, malignant neoplasms were observed in 20 of 4,127 (0.5%) omalizumab-treated patients compared with 5 of 2,236 (0.2%) control patients. The observed new primary malignancy types in omalizumab-treated patients varied, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and 5 other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to omalizumab or use in patients at higher risk for malignancy (e.g., elderly, current smokers) is not known. In a subsequent observational study of 5,007 omalizumab-treated and 2,829 non-omalizumab-treated adolescent and adult patients with moderate to severe persistent asthma and a positive skin test reaction or in vitro reactivity to a perennial aeroallergen, patients were followed for up to 5 years. In this study, the incidence rates of primary malignancies (per 1,000 patient-years) were similar among omalizumab-treated (12.3) and non-omalizumab-treated patients (13). However, study limitations preclude definitively ruling out a malignancy risk with omalizumab. Study limitations include the observational study design, the bias introduced by allowing enrollment of patients previously exposed to omalizumab (88%), enrollment of patients (56%) while a history of cancer or a premalignant condition were trial exclusion criteria, and the high study discontinuation rate (44%).[44070]

    Helminth infection

    Monitor patients at high risk of geo-helminth infection while on omalizumab therapy. Insufficient data are available to determine the length of monitoring required for geo-helminth infections in these patients after stopping omalizumab treatment. In a one-year clinical trial conducted in Brazil in adult and adolescent patients at high risk for geo-helminth infection, as diagnosed by standard stool examination, compared to 42% (29/69) of placebo controls. The point estimate of the odds ratio for infection was 1.96 (95% CI, 0.88, 4.36); the study indicated that a patient with geo-helminth infection was anywhere from 0.88 to 4.36 times as likely to have received omalizumab than a patient who did not have an infection. Response to appropriate treatment of geo-helminth infection, as measured by stool egg counts, was not different between treatment groups.[44070]

    Pregnancy

    The data with omalizumab use during human pregnancy are insufficient to inform a drug-associated risk. There are no adequate and well-controlled studies in pregnant women and its ability to cause fetal harm or affect reproductive capacity is unknown. Monoclonal antibodies, such as omalizumab, are known to cross the placenta; therefore, omalizumab may be transmitted from the mother to the fetus. A registry study of omalizumab exposure in 250 pregnant women showed no increase in the rate of major birth defects or miscarriage. Although there was an increased rate of low birth weight among registry infants compared to infants in the other cohorts, women taking omalizumab during pregnancy had more severe asthma, which makes it difficult to determine if the low birth weight is due to the drug or disease severity. In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Thus, asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.

    Breast-feeding

    There are limited data regarding the use of omalizumab during breast-feeding. There is no information regarding the presence of omalizumab in human milk or the effects on milk production. A majority of the infants (80.9%, 186/230) in the pregnancy registry study of omalizumab were breastfed. Events categorized as "infections and infestations" were not significantly increased in infants exposed to omalizumab compared with infants who were not breastfed or infants who were breastfed without exposure to omalizumab. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.[44070]

    Children, infants, neonates

    Safety and efficacy of omalizumab for asthma and chronic idiopathic urticaria have not been established in neonates, infants, and children less than 6 years of age. Safety and efficacy of omalizumab for nasal polyps have not been established in patients less than 18 years of age.

    Latex hypersensitivity

    Omalizumab prefilled syringes should be administered cautiously to patients with a possible history of latex hypersensitivity because the needle cap contains a derivative of natural rubber latex.

    ADVERSE REACTIONS

    Severe

    bone fractures / Delayed / 2.0-2.0
    new primary malignancy / Delayed / 0.5-0.5
    angioedema / Rapid / 0.1-0.2
    bronchospasm / Rapid / 0.1-0.2
    serum sickness / Delayed / Incidence not known
    serious hypersensitivity reactions or anaphylaxis / Rapid / Incidence not known
    vasculitis / Delayed / Incidence not known
    Churg-Strauss syndrome / Delayed / Incidence not known
    pulmonary embolism / Delayed / Incidence not known
    pulmonary hypertension / Delayed / Incidence not known
    thromboembolism / Delayed / Incidence not known
    stroke / Early / Incidence not known
    thrombosis / Delayed / Incidence not known
    myocardial infarction / Delayed / Incidence not known

    Moderate

    dyspnea / Early / 0.1-0.2
    antibody formation / Delayed / 0-0.1
    cystitis / Delayed / 2.0
    migraine / Early / 2.0
    peripheral edema / Delayed / 2.0
    erythema / Early / Incidence not known
    lymphadenopathy / Delayed / Incidence not known
    hypotension / Rapid / Incidence not known
    thrombocytopenia / Delayed / Incidence not known
    eosinophilia / Delayed / Incidence not known
    angina / Early / Incidence not known

    Mild

    injection site reaction / Rapid / 0.6-45.0
    infection / Delayed / 0.5-23.0
    sinusitis / Delayed / 1.1-16.0
    pharyngitis / Delayed / 6.6-11.0
    arthralgia / Delayed / 2.9-8.0
    dizziness / Early / 3.0-3.0
    fatigue / Early / 3.0-3.0
    abdominal pain / Early / 3.0-3.0
    nausea / Early / 1.1-2.7
    cough / Delayed / 1.1-2.2
    pruritus / Rapid / 2.0-2.0
    otalgia / Early / 2.0-2.0
    syncope / Early / 0.1-0.2
    fever / Early / 2.0
    urticaria / Rapid / 2.0
    alopecia / Delayed / 2.0
    anxiety / Delayed / 2.0
    headache / Early / 3.0
    dental pain / Delayed / 2.0
    epistaxis / Delayed / 3.0
    myalgia / Early / 2.0
    musculoskeletal pain / Early / 2.0
    rash / Early / Incidence not known

    DRUG INTERACTIONS

    Cholera Vaccine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the live cholera vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to cholera bacteria after receiving the vaccine.
    SARS-CoV-2 (COVID-19) vaccines: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine.

    PREGNANCY AND LACTATION

    Pregnancy

    The data with omalizumab use during human pregnancy are insufficient to inform a drug-associated risk. There are no adequate and well-controlled studies in pregnant women and its ability to cause fetal harm or affect reproductive capacity is unknown. Monoclonal antibodies, such as omalizumab, are known to cross the placenta; therefore, omalizumab may be transmitted from the mother to the fetus. A registry study of omalizumab exposure in 250 pregnant women showed no increase in the rate of major birth defects or miscarriage. Although there was an increased rate of low birth weight among registry infants compared to infants in the other cohorts, women taking omalizumab during pregnancy had more severe asthma, which makes it difficult to determine if the low birth weight is due to the drug or disease severity. In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Thus, asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control.

    There are limited data regarding the use of omalizumab during breast-feeding. There is no information regarding the presence of omalizumab in human milk or the effects on milk production. A majority of the infants (80.9%, 186/230) in the pregnancy registry study of omalizumab were breastfed. Events categorized as "infections and infestations" were not significantly increased in infants exposed to omalizumab compared with infants who were not breastfed or infants who were breastfed without exposure to omalizumab. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.[44070]

    MECHANISM OF ACTION

    Omalizumab binds to human IgE's high affinity Fc receptor (Fc epsilonRI), preventing the binding of IgE to a variety of cells associated with the allergic response and lowering free serum IgE concentrations. Avoiding the bridging between IgE and cells associated with allergic response prevents degranulation of such cells and, thereby, the release of inflammatory mediators. The early phase of allergic response is prevented as omalizumab prohibits IgE's binding to mast cells, preventing mast cell degranulation. The late phase of allergic response is prevented when the IgE-anti-IgE complex is unable to bind to (Fc epsilonRI) receptors on monocytes, eosinophils, dendritic cells, epithelial cells, and platelets, thus interfering with mediator/cytokine release. Omalizumab indirectly causes a notable down-regulation of (Fc epsilonRI) on basophils, and also prevents IgE from interacting with low affinity Fc receptors ((Fc epsilonRII)) on antigen-presenting cells. IgE-anti-IgE complexes are non-immunogenic with a half-life of about 40 days and persist in circulation for a prolonged time; these hexamers have unoccupied antigen binding sites and are able to remove from the circulation those allergens against which the patient's IgE is directed. Omalizumab has been found in clinical trials to reduce free serum IgE concentrations by more than 90%, considerably suppress eosinophils in induced sputum, and blunt both early and late phase allergic responses.

    PHARMACOKINETICS

    Omalizumab is administered by subcutaneous injection. Once omalizumab is in the serum, it forms complexes of limited size with IgE; there is no evidence of omalizumab distribution into any other tissues or organs. The apparent volume of distribution of omalizumab in patients with asthma following subcutaneous administration was 78 +/- 32 mL/kg; distribution of omalizumab was similar in patients with chronic idiopathic urticaria (CIU). Clearance of omalizumab involved IgG clearance processes as well as clearance via specific binding and complex formation with its target ligand, IgE. Liver elimination of IgG included degradation in the liver reticuloendothelial system (RES) and endothelial cells. Intact IgG was also excreted in bile. In studies with mice and monkeys, omalizumab:IgE complexes were eliminated by interactions with Fc-gamma receptors within the RES at rates that were generally faster than IgG clearance. In asthma patients, the omalizumab serum elimination half-life averaged 26 days, with apparent clearance averaging 2.4 +/- 1.1 mL/kg/day. Doubling body weight approximately doubled the apparent clearance in these patients. Studies suggested the pharmacokinetics of omalizumab in nasal polyps were consistent with that in asthma. In CIU patients, at steady state, based on population pharmacokinetics, omalizumab serum elimination half-life averaged 24 days and apparent clearance averaged 240 mL/day (corresponding to 3 mL/kg/day for an 80 kg patient).
     
    In patients with asthma, serum free IgE concentrations are reduced in a dose dependent manner within 1 hour of the first dose of omalizumab and are maintained between doses. The mean serum free IgE decrease is greater than 96% when using recommended dosages. Serum total IgE levels (i.e., bound and unbound) increase after the first dose due to the formation of omalizumab:IgE complexes, which have a slower elimination rate compared to free IgE. At 16 weeks after the first dose, average serum total IgE levels are 5-fold higher compared with pre-treatment when using standard assays. After discontinuation of omalizumab, the omalizumab-induced increase in total IgE and decrease in free IgE are reversible, with no observed rebound in IgE concentrations after drug washout. Total IgE concentrations do not appear to return to pre-treatment levels for up to 1 year after discontinuation of omalizumab.
     
    In patients with CIU, omalizumab treatment led to a dose-dependent reduction of serum free IgE and an increase of serum total IgE levels, similar to the observations in asthma patients. Maximum suppression of free IgE was observed 3 days following the first subcutaneous dose. After repeat dosing once every 4 weeks, predose serum free IgE levels remained stable between 12 and 24 weeks of treatment. Total IgE levels in serum increased after the first dose due to the formation of omalizumab-IgE complexes which have a slower elimination rate compared with free IgE. After repeat dosing once every 4 weeks at 75 mg up to 300 mg, average predose serum total IgE levels at Week 12 were 2- to 3-fold higher compared with pre-treatment levels, and remained stable between 12 and 24 weeks of treatment. After discontinuation of omalizumab dosing, free IgE levels increased and total IgE levels decreased towards pre-treatment levels over a 16-week follow-up period.
     
    In patients with nasal polyps, omalizumab treatment led to a reduction in serum free IgE and an increase in serum total IgE levels, similar to the observations in asthma patients. The mean total IgE concentrations at baseline were 168 IU/mL and 218 IU/mL in Nasal Polyp Trial 1 and 2, respectively. After repeated dosing every 2 or 4 weeks, with dosage and frequency according to Table 3, the mean predose free IgE concentrations at Week 16 were 10.0 IU/mL in Trial 1 and 11.7 IU/mL in Trial 2 and remained stable at 24 weeks of treatment. Total IgE levels in serum increased due to the formation of omalizumab-IgE complexes, which have a slower elimination rate compared with free IgE. After repeated dosing every 2 or 4 weeks, with dosage and frequency according to Table 3, mean and median predose serum total IgE levels at Week 16 were 3-to 4-fold higher compared with pre-treatment levels, and remained stable between 16 and 24 weeks of treatment.
     
    Affected cytochrome P450 isoenzymes and drug transporters: None

    Subcutaneous Route

    After subcutaneous administration, omalizumab is absorbed slowly into the serum where it forms complexes with IgE. Maximum serum concentrations are achieved within 7 to 8 days. The average absolute bioavailability is 62%.