Omalizumab Side Effects

Some side effects of omalizumab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to omalizumab: subcutaneous powder for injection

Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.

Get emergency medical help if you have any of these signs of an allergic reaction while taking omalizumab:

• wheezing, tightness in your chest, trouble breathing;

• hives or skin rash;

• feeling anxious or light-headed, fainting;

• warmth or tingling under your skin; or

• swelling of your face, lips, tongue, or throat.

Other serious side effects include easy bruising or bleeding, numbness, or unusual weakness.

Less serious side effects of omalizumab may include:

• pain;

• headache, tired feeling;

• joint or muscle pain;

• dizziness;

• ear pain;

• hair loss;

• mild itching or skin rash;

• sore throat or cold symptoms; or

• redness, bruising, warmth, burning, stinging, itching, pain, or swelling of your skin where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to omalizumab: subcutaneous powder for injection

Hypersensitivity

Anaphylaxis usually occurred within two hours of receiving a omalizumab subcutaneous injection. However, recent reports include patients who had delayed anaphylaxis with onset two to 24 hours or even longer after receiving omalizumab treatment. Anaphylaxis may occur after any dose of omalizumab including the first dose. Health care professionals who administer omalizumab should be prepared to manage life-threatening anaphylaxis and should observe their omalizumab-treated patients for at least two hours after omalizumab is given. Patients under treatment with omalizumab should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following omalizumab treatment, and how to treat it when it occurs.

Hypersensitivity reactions including anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab. Anaphylaxis has occurred as early as after the first dose of omalizumab, 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 omalizumab administration, and health care providers administering omalizumab 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.

Local

Local side effects have included injection site reactions in 45% of patients, including bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation. Severe injection site reactions occurred in 12% of patients (vs 9% with placebo). Most reactions occurred within 1 hour after injection, lasted for 8 days or less, and decreased in frequency with subsequent doses.

Cardiovascular

Cardiovascular side effects have been reported including a study showing a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic, and thrombophlebitic events in patients treated with omalizumab compared to a control group of patients not given the drug.

Dermatologic

Dermatologic side effects have included pruritus (2%) and dermatitis (2%).

Respiratory

Respiratory side effects have included upper respiratory tract infection (20%), sinusitis (16%), and pharyngitis (11%).

Nervous system

Nervous system side effects have included headache (15%) and dizziness (3%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (8%), fracture (2%), leg pain (4%), and arm pain (2%).

Oncologic

Oncologic side effects have included malignancies in 0.5% of patients (n=4127) compared with 0.2% of control patients (n=2236). The types of malignancies in omalizumab-treated patients included breast, skin (nonmelanoma), prostate, melanoma, and parotid.

Other

Other side effects have included viral infections (23%), pain (7%), fatigue (3%), and earache (2%). Three cases of Churg-Strauss syndrome have also been reported.

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