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XOLAIR (Omalizumab) for Subcutaneous Use Indication

XOLAIR is indicated for adults and adolescents (12 years of age and older) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with ICS. XOLAIR has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.

WARNING

Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, patients should be closely observed for an appropriate period of time after XOLAIR administration, and health care providers administering XOLAIR should be prepared to manage anaphylaxis that can be life-threatening. Patients should also be informed of the signs and symptoms of anaphylaxis and instructed to seek immediate medical care should symptoms occur (see WARNINGS, and PRECAUTIONS, Information for Patients).

XOLAIR Safety Information

  • XOLAIR should only be administered in a health care setting by health care providers prepared to manage anaphylaxis that can be life- threatening.
  • XOLAIR should not be administered to patients who have experienced a severe hypersensitivity reaction to XOLAIR (see Boxed WARNING). XOLAIR should be discontinued in patients who experience a severe hypersensitivity reaction.
  • Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR- treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of asthma and other allergic disorders.
  • Patients should be given and instructed to read the Medication Guide before starting treatment and before each subsequent treatment.
  • Patients receiving XOLAIR should be told not to decrease the dose of, or stop taking any other asthma medications unless otherwise instructed by their physician.
  • The adverse reactions most commonly observed among patients treated with XOLAIR in clinical studies included injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events were observed at similar rates in XOLAIR-treated patients and control patients.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.

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