FDA Adds Black Box Warning to Xolair Label

Yael Waknine

Disclosures

July 03, 2007

July 3, 2007 — The safety labeling for omalizumab subcutaneous injection ( Xolair, Genentech, Inc) has been updated with a black box warning to advise healthcare professionals of the risk for anaphylaxis associated with its use, the US Food and Drug Administration (FDA) said yesterday. An follow-up alert was sent today from MedWatch, the FDA's adverse event reporting program.

Three cases of anaphylaxis were reported among 3507 patients exposed to the drug in clinical trials; postmarketing reports suggest that the incidence rate is approximately 0.2%. Symptoms included bronchospasm, hypotension, syncope, urticaria, angioedema of the throat/tongue, dyspnea, cough, chest tightness, cutaneous angioedema, and generalized pruritis. Approximately 89% of patients had pulmonary involvement; 14% had hypotension or syncope, and 15% required hospitalization.

Although the rate of anaphylaxis was highest after initial dosing (39%), cases have also occurred after more than 1 year of treatment. For many cases (59%), onset occurred within 2 hours of the injection; 14% occurred within 6 to 12 hours, and 22% were been reported more than 24 hours after treatment.

Healthcare professionals should be aware of the risk for delayed-onset reactions and are advised to provide direct medical supervision during and after each injection of omalizumab. Trained personnel should be able to recognize anaphylaxis and treat it appropriately with available medication and equipment. Omalizumab treatment should be discontinued in patients who experience a severe hypersensitivity reaction.

The FDA notes that the need for continued omalizumab therapy should be periodically evaluated based on the patient’s disease severity and level of asthma control.

A new medication guide, to be distributed with each dose of omalizumab injection, has also been approved to inform patients of the risk for anaphylaxis and related symptoms. Patients are also instructed to carry medical information and be fully prepared to begin treatment for anaphylaxis, including use of an epinephrine auto-injector and obtaining immediate medical attention for recognized symptoms.

Omalizumab is indicated for the treatment of moderate to severe persistent asthma in patients aged 12 years and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

Healthcare professionals are encouraged to report omalizumab-related adverse events to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

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