Omalizumab is used to treat moderate to severe asthma that is caused by allergies in adults and children who are at least 6 years old. Omalizumab is used when asthma symptoms are not controlled by asthma inhaled steroid medicine. Omalizumab is not a rescue medicine for treating an asthma attack.

Omalizumab is used to treat nasal polyps in adults when nasal steroid medicine did not work.

Omalizumab is also used to treat chronic hives (idiopathic urticaria) in adults and children at lest 12 years old, when antihistamines have not worked.

Omalizumab is not for use in treating other allergies, rashes, or attacks of bronchospasm.

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

You should not use omalizumab if you are allergic to it.

Tell your doctor if you have any signs of infection (fever, swollen glands, general ill feeling), or if you have ever had:

• any other allergies (foods, pollens, etc);
• allergy shots;
• a severe allergic reaction (anaphylaxis);
• an infection caused by parasites (such as giardia, malaria, leishmaniasis, hookworm, pinworm, toxoplasmosis, and many others);
• a heart attack or stroke;
• cancer; or
• a latex allergy.

Using this medicine 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.

While you are using omalizumab, you may also have an increased risk of becoming infected with parasites (worms) if you live in or travel to areas where such infections are common. Talk with your doctor about what to look for and how to treat this condition.

Some babies born to mothers using omalizumab during pregnancy had low birth weight. However, it is not known whether this was due to omalizumab use or to severe asthma in the mothers. The benefit of treating asthma may outweigh any risks to the baby. Tell your doctor if you are pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of omalizumab on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Use Xolair Prefilled Syringe (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

You will be watched closely for a short time after each injection, to make sure you do not have an allergic reaction to omalizumab.

Get emergency medical help if you have signs of an allergic reaction:

• hives, itching;
• anxiety or fear, feeling like you might pass out;
• flushing (warmth, redness, or tingly feeling);
• chest tightness, wheezing, cough, feeling short of breath, difficult breathing;
• fast or weak heartbeats; or
• swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• ongoing nausea or vomiting, severe or watery diarrhea;
• trouble breathing;
• numbness or tingling in your arms or legs;
• fever, muscle pain, and rash within a few days after receiving an injection;
• signs of an ear infection--fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder; or
• signs of a blood clot--sudden numbness or weakness, problems with vision or speech, coughing up blood, swelling or redness in an arm or leg.

Common side effects may include:

• rash;
• fever;
• nosebleeds;
• joint pain, bone fractures;
• arm or leg pain;
• nausea, vomiting, diarrhea, stomach pain;
• headache;
• dizziness, feeling tired;
• ear pain, ear infection;
• pain, bruising, swelling, or irritation where the medicine was injected; or
• cold symptoms such as stuffy nose, sneezing, sinus pain, cough, sore throat.

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.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.