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 6 years old. It 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 chronic hives (idiopathic urticaria) in adults and children who are at least 12 years old, after antihistamines have been tried without success.

Omalizumab is also used to treat nasal polyps in people 18 years of age and older when lled nasal corticosteroid medicines have not worked well.

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

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

Get emergency medical help if you have any signs of an allergic reaction to omalizumab: hives, rash; anxiety or fear; flushing (warmth, redness, or tingly feeling); feeling like you might pass out; chest tightness, wheezing, feeling short of breath, difficult breathing; fast or weak heartbeats; 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 an oral 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 omalizumab 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.

Omalizumab is injected under the skin. A healthcare provider will give you this injection every 2 or 4 weeks.

Your doctor may perform an allergy skin test or blood test to make sure this medicine is right for you.

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

Omalizumab doses are based on weight. Your dose needs may change if you gain or lose weight.

If you also use a steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.

You may need frequent medical tests, such as allergy tests and lung function tests. Your stools may also need to be checked for parasites, especially if you travel.

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 omalizumab 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 use of this medicine 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.

Call your doctor for instructions if you miss an appointment for your omalizumab injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Some people using this medicine have had a severe, life-threatening allergic reaction to omalizumab, 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 to omalizumab:

• 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 omalizumab 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.

Other drugs may interact with omalizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.