When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive this medicine if you had an allergic reaction to omalizumab.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other health provider will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. Be sure to keep all appointments.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding.
• This medicine will not stop an asthma attack that has already started. Your doctor may prescribe another medicine for you to use in case of an asthma attack.
• If you use a corticosteroid medicine (inhaled or taken by mouth) to control your asthma, keep using it unless your doctor tells you otherwise.
• You may not see immediate improvement in your asthma after omalizumab treatment begins. It takes time for the medicine to work. It is important to continue your omalizumab injections until your doctor tells you otherwise.
• This medicine may cause the following problems:
  
  • Eosinophilia (increased white blood cell count)
  • Vasculitis (inflammation of the blood vessels)
  • Increased risk of cancer or infections
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fast heartbeat, trouble breathing, or chest pain
• Fever, joint or muscle pain, rash
• Lightheadedness, dizziness, or fainting
• Swollen, painful, or tender lymph glands in the neck, armpit, or groin

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or lump under your skin where the shot was given
• Stuffy or runny nose

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088