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  • CLASSES

    All Other Anti-asthma and COPD Products, Systemic

    DEA CLASS

    Rx

    DESCRIPTION

    Monoclonal antibody directed against IgE
    Approved for the treatment of moderate to severe allergic asthma and chronic idiopathic urticaria
    Although rare, anaphylactic reactions may develop after the first dose or during ongoing treatment

    COMMON BRAND NAMES

    Xolair

    HOW SUPPLIED

    Xolair Subcutaneous Inj Pwd F/Sol: 202.5mg

    DOSAGE & INDICATIONS

    For moderate to severe persistent asthma in patients with a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroid.
    NOTE: Total IgE concentrations are elevated during treatment and remain elevated for up to 1 year after treatment is discontinued; therefore, serum IgE concentrations during treatment cannot be used as a guide for dosage determination. Periodically reassess the need for continued therapy based upon the patient's disease severity and level of asthma control.
    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    Adults weighing 30 to 90 kg

    150 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

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

    150 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    Children 6 to 11 years weighing 41 to 90 kg

    150 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    Children 6 to 11 years weighing 20 to 40 kg

    75 mg subcutaneously every 4 weeks. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    Adults weighing 30 to 90 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    Children 6 to 11 years weighing 20 to 40 kg

    150 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    Adults weighing 61 to 90 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    Adults weighing 30 to 60 kg

    300 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    Children 6 to 11 years weighing 20 to 30 kg

    150 mg subcutaneously every 4 weeks. Do not administer more than 150 mg per injection site. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    Adults weighing 30 to 70 kg

    225 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    Adults weighing 30 to 70 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    Adults weighing 30 to 60 kg

    300 mg subcutaneously every 2 weeks. Do not administer more than 150 mg per injection site. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    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. Monitor patients closely after administration for anaphylaxis. Adjust doses for significant changes in body weight. If treatment is interrupted for less than 1 year, restart omalizumab based on the initial baseline serum IgE concentration. If treatment is interrupted for 1 year or more, determine the dosage based on IgE concentration at the time of omalizumab re-initiation.

    For the treatment of chronic idiopathic urticaria in patients who remain symptomatic despite H1 antihistamine treatment.
    Subcutaneous dosage
    Adults, Adolescents, and Children 12 years of age

    150 mg or 300 mg subcutaneously every 4 weeks. The optimal treatment duration has not been evaluated. Periodically reassess the need for continued treatment. Dosing is not based on serum IgE concentrations or body weight. 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 treatment of seasonal allergic rhinitis†.
    NOTE: Total IgE concentrations are elevated during treatment and remain elevated for up to 1 year after treatment is discontinued. The monitoring of IgE concentrations during treatment cannot be used as a guide for dosage determination. If treatment is interrupted for less than 1 year, the restarting dose should be based on serum IgE levels obtained at the initial dosage determination. Dosage should be adjusted for significant changes in body weight.
    Subcutaneous dosage
    Adults

    In clinical trials, a dosage of 300 mg subcutaneously every 3—4 weeks (frequency based on serum IgE levels) has been used for up to 8 weeks; minimum doses of 0.016 mg/kg/IgE (units/mL) subcutaneously every 4 weeks have also been used.

    Children and Adolescents

    In clinical trials, a minimum dose of 0.016 mg/kg/IgE (units/mL) subcutaneously every 4 weeks for up to 24 weeks has been used.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    For the treatment of asthma: 750 mg/4 weeks subcutaneous.
    For the treatment of chronic idiopathic urticaria: 300 mg/4 weeks subcutaneous.

    Geriatric

    For the treatment of asthma: 750 mg/4 weeks subcutaneous.
    For the treatment of chronic idiopathic urticaria: 300 mg/4 weeks subcutaneous.

    Adolescents

    For the treatment of asthma: 750 mg/4 weeks subcutaneous.
    For the treatment of chronic idiopathic urticaria: 300 mg/4 weeks subcutaneous.

    Children

    12 years:
    For the treatment of asthma: 750 mg/4 weeks subcutaneous.
    For the treatment of chronic idiopathic urticaria: 300 mg/4 weeks subcutaneous.
    6 to 11 years:
    For the treatment of asthma: 750 mg/4 weeks subcutaneous.
    For the treatment of chronic idiopathic urticaria: Safety and efficacy have not been established.
    1 to 5 years: Safety and efficacy have not been established.

    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

    Administration of omalizumab should only be done in a healthcare setting by providers who are prepared to identify and treat anaphylaxis, which may occur after any dose of the drug and up to 4 days after drug receipt. Observe the patient for an appropriate time after each injection, and instruct the patient to get immediate medical care if signs or symptoms of anaphylaxis develop.
    Periodically reassess the need for continued omalizumab receipt based on the patient's disease severity.
     
    Reconstitution/Dilution:
    Reconstitute by injecting 1.4 mL of Sterile Water for Injection into the vial of omalizumab.
    Keeping the vial upright, gently swirl for approximately 1 minute to evenly wet the powder; do not shake.
    Allow the vial to stand, and approximately every 5 minutes gently swirl the vial for 5 to 10 seconds 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 reconstituted product is somewhat viscous; once reconstituted, the concentration is 150 mg/1.2 mL (i.e., 125 mg/mL). In order to obtain the full 1.2 mL dose, all of the product must be withdrawn from the vial before expelling any air or excess solution from the syringe. To obtain a volume of 0.6 mL (corresponding to 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.
    Storage: The 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 reconstituted injection from direct sunlight.
     
    Subcutaneous Injection:
    The reconstituted solution is slightly viscous, and the subcutaneous injection may take 5 to 10 seconds to administer.
    Each subcutaneous injection should not exceed 150 mg (1.2 mL) per site; doses of more than 150 mg should be divided among more than one subcutaneous injection site.

    STORAGE

    Xolair:
    - Protect from light
    - 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)

    CONTRAINDICATIONS / PRECAUTIONS

    Hamster protein hypersensitivity, omalizumab hypersensitivity, risk of 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 hypersensitivity reaction to the drug. Anaphylaxis has occurred after the first omalizumab dose but also has occurred after 1 year of regularly administered treatment. Anaphylaxis occurred in approximately 0.1% of patients during clinical trials with omalizumab; post-marketing cases also exist. A retrospective case-control study demonstrated that patients with anaphylaxis to omalizumab were more likely to have a history of anaphylaxis to other causes, including food or other medications, compared to controls with no prior history of anaphylaxis. Anaphylaxis has been reported to occur up to 4 days after administration of a dose of omalizumab. Documented signs and symptoms have included angioedema of the throat or tongue, bronchospasm, hypotension, syncope, and urticaria. Closely observe patients for an appropriate period of time after omalizumab administration because of the risk of anaphylaxis; health care providers who administer omalizumab should be prepared to manage anaphylaxis that can be life-threatening. Instruct patients on the signs and symptoms of anaphylaxis including the potential for a delayed reaction to the drug. Also, instruct patients to seek immediate medical care should symptoms occur. In addition, patients should carry emergency anaphylactic self-treatment and be familiar with instructions for use.

    Acute bronchospasm, corticosteroid therapy, peripheral neuropathy, respiratory insufficiency, status asthmaticus, vasculitis

    Omalizumab has not been shown to alleviate asthma exacerbations acutely and should not be used for the treatment of acute bronchospasm or status asthmaticus. During omalizumab therapy, asthmatic patients receiving omalizumab should be told not to decrease the dose of, or stop taking, any other asthma medications unless otherwise instructed by their prescriber. Specifically, systemic or inhaled corticosteroids should not be abruptly discontinued upon initiation of omalizumab therapy. Decreases in corticosteroid therapy during omalizumab should be performed under the direct supervision of a prescriber and may need to be performed gradually. Additionally, clinicians should monitor for signs and symptoms of eosinophilia, vasculitic rash, worsening pulmonary symptoms or respiratory insufficiency, cardiac complications, and/or peripheral neuropathy presenting in patients. In rare cases, patients receiving omalizumab may present with serious systemic eosinophilia sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome. A causal relationship has not been determined. These events usually, but not always, have been associated with the reduction of oral corticosteroid doses.

    Lymphoma, neoplastic disease, secondary malignancy

    Use omalizumab cautiously in patients with a history of systemic neoplastic disease and in patients with a high risk for malignancy (i.e., tobacco smokers, elderly). In clinical trials, 0.5% of patients treated with omalizumab, compared to 0.2% of placebo-treated patients, developed a secondary malignancy. A variety of malignancies developed, including lymphoma. In 2014, the FDA announced that review of a 5-year safety study of 5007 omalizumab-treated and 2829 non-omalizumab-treated patients found no difference in the incidence rates of malignancies (per 1000 patient years) between those patients being treated with omalizumab (12.3) and those who were not being treated with the drug (13). However, the FDA cannot rule out a potential risk of malignancy with omalizumab due to limitations in the 5-year study, including 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 study exclusion criteria, and the high study discontinuation rate (44%).

    Vaccination

    There are no data examining the responses to vaccination in patients receiving omalizumab. Live virus vaccines should be given cautiously during omalizumab treatment until more data are available.

    Children, infants, neonates

    Safety and efficacy of omalizumab have not been established in neonates, infants and children < 12 years of age. According to the manufacturer, potential benefits do not outweigh the risks associated with omalizumab use in this population. Safety and effectiveness were evaluated in two clinical trials that included 926 children ages 6 to < 12 years. Although no children in these two studies experienced anaphylaxis or malignancy (two of the most severe risks associated with omalizumab use), neither study design nor duration was adequate to evaluate these risks. In one of these trials, there was no statistically significant difference found between the treatment and placebo groups for most efficacy variables.

    Pregnancy

    The data with omalizumab use in pregnant women are insufficient to inform on 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 transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters of pregnancy. According to the manufacturer, 27 women became pregnant during their involvement in clinical studies (17 omalizumab group; 10 control group). Of these patients, 11 in the omalizumab group and 6 in the control group had normal deliveries and no effects on the infants were reported; pregnancy loss or termination occurred in 3 of the omalizumab patients and 2 of the control patients. During all studies, use of the drug was discontinued in patients with on-going pregnancies. In animal studies, no evidence of fetal harm was observed in monkeys with doses of omalizumab up to 10 times the maximum recommended human dose (MRHD). The manufacturer recommends use during pregnancy only if clearly needed.

    Breast-feeding

    Maternal antibodies are known to be present in breast milk; however, data are limited regarding use of omalizumab during breast-feeding, and its excretion in human milk is unknown. The drug is a protein and would likely be digested in the infants gastrointestinal tract, although exposure and effects on the nursing infant are unknown. Because of the lack of data, alternate treatment in a breast-feeding women may be prudent. The manufacturer recommends caution when administering to lactating women. 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, health care providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Severe

    bone fractures / Delayed / 2.0-2.0
    bronchospasm / Rapid / 0.1-0.2
    anaphylactoid reactions / Rapid / 0.1-0.2
    angioedema / Rapid / 0.1-0.2
    serum sickness / Delayed / Incidence not known
    vasculitis / Delayed / Incidence not known
    Churg-Strauss syndrome / Delayed / Incidence not known
    stroke / Early / Incidence not known
    thromboembolism / Delayed / Incidence not known
    pulmonary embolism / Delayed / Incidence not known
    myocardial infarction / Delayed / Incidence not known
    pulmonary hypertension / Delayed / Incidence not known
    thrombosis / Delayed / Incidence not known

    Moderate

    secondary malignancy / Delayed / 0.5-0.5
    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
    eosinophilia / Delayed / Incidence not known
    thrombocytopenia / Delayed / Incidence not known
    angina / Early / Incidence not known
    hypotension / Rapid / 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
    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
    alopecia / Delayed / 2.0
    urticaria / Rapid / 2.0
    headache / Early / 3.0
    anxiety / Delayed / 2.0
    myalgia / Early / 2.0
    musculoskeletal pain / Early / 2.0
    abdominal pain / Early / 3.0
    epistaxis / Delayed / 3.0
    rash (unspecified) / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Omalizumab products.

    PREGNANCY AND LACTATION

    Pregnancy

    The data with omalizumab use in pregnant women are insufficient to inform on 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 transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters of pregnancy. According to the manufacturer, 27 women became pregnant during their involvement in clinical studies (17 omalizumab group; 10 control group). Of these patients, 11 in the omalizumab group and 6 in the control group had normal deliveries and no effects on the infants were reported; pregnancy loss or termination occurred in 3 of the omalizumab patients and 2 of the control patients. During all studies, use of the drug was discontinued in patients with on-going pregnancies. In animal studies, no evidence of fetal harm was observed in monkeys with doses of omalizumab up to 10 times the maximum recommended human dose (MRHD). The manufacturer recommends use during pregnancy only if clearly needed.

    Maternal antibodies are known to be present in breast milk; however, data are limited regarding use of omalizumab during breast-feeding, and its excretion in human milk is unknown. The drug is a protein and would likely be digested in the infants gastrointestinal tract, although exposure and effects on the nursing infant are unknown. Because of the lack of data, alternate treatment in a breast-feeding women may be prudent. The manufacturer recommends caution when administering to lactating women. 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, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Mechanism of Action: Omalizumab binds to human IgE's high affinity Fc receptor (FcepsilonRI), 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 FcepsilonRI receptors on monocytes, eosinophils, dendritic cells, epithelial cells, and platelets, thus interfering with mediator/cytokine release. Omalizumab indirectly causes a notable down-regulation of FcepsilonRI on basophils, and also prevents IgE from interacting with low affinity Fc receptors (FcepsilonRII) 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 (SC) injection. Once omalizumab is in the serum, it forms complexes with IgE; there is no evidence of omalizumab distribution into any other tissues or organs. 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 five-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 one year after discontinuation of omalizumab. Omalizumab elimination is slow with a terminal half-life of 22 +/- 9 days. The slow clearance of omalizumab is consistent with recycling of IgG1 class immunoglobulins via the FcRn receptor system; the omalizumab:IgE complexes are believed to clear via interactions with Fc-gamma receptors within the reticuloendothelial system.

    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—8 days. The average absolute bioavailability is 62%.