Brand Names: Xolair

Generic Name: omalizumab (Pronunciation: OH ma LIZ oo mab)

• What is omalizumab (Xolair)?
• What are the possible side effects of omalizumab (Xolair)?
• What is the most important information I should know about omalizumab (Xolair)?
• What should I discuss with my healthcare provider before using omalizumab (Xolair)?
• How should I use omalizumab (Xolair)?
• What happens if I miss a dose (Xolair)?
• What happens if I overdose (Xolair)?
• What should I avoid while using omalizumab (Xolair)?
• What other drugs will affect omalizumab (Xolair)?
• Where can I get more information?

What is omalizumab (Xolair)?

Omalizumab is an antibody that helps decrease allergic responses in the body.

Omalizumab is used to treat moderate to severe asthma that is caused by allergies in adults and children who are at least 12 years old.

Omalizumab is usually given after other asthma medications have been tried without successful treatment of symptoms.

Omalizumab may also be used for purposes not listed in this medication guide.

What are the possible side effects of omalizumab (Xolair)?

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:

• 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the Xolair (omalizumab) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about omalizumab (Xolair)?

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: 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.

Asthma is often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks.

Your symptoms may not improve right away once you start receiving omalizumab. For best results, keep receiving the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Use omalizumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Using this medication may increase your risk of certain types of cancers of the breast, skin, prostate, or salivary gland. Talk to your doctor about your individual risk.