This medication can cause a very serious (sometimes fatal) allergic reaction. In many cases, this type of reaction occurred after the first dose, but it can occur with any later doses. This type of reaction usually occurred within 24 hours or up to 4 days after receiving this medication. Your health care professional will monitor you closely during treatment for any signs of an allergic reaction. Seek immediate medical attention if at any time you develop any signs of an allergic reaction including: trouble breathing, cough, chest tightness, rash, itching, swelling (especially of the throat, tongue), hives, dizziness.

If you have had an allergic reaction to omalizumab, you must never use omalizumab again.

This medication is used to treat moderate to severe asthma in adults and children over 12 years of age. It works by blocking your immune system's natural response to allergic triggers that can lead to an acute asthma attack. This action on your immune system (specifically immunoglobulin E-IgE), helps keep your air passages open and, over time, it keeps your asthma in better control.

This medication does not work immediately and should not be used for the quick relief of an acute asthma attack.

Read the Medication Guide provided by your pharmacist before you start using omalizumab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is injected under the skin (subcutaneously-SC) by a health care professional, usually every 2 or 4 weeks as directed by your doctor. Health care professionals must follow all the manufacturer's instructions for properly preparing and giving this drug. Check this product visually for particles or discoloration before using. If either is present, do not use the liquid. If you have any questions about using this medication properly, consult your doctor or pharmacist.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it on the same day of the week according to your schedule. It may take up to several months of continued use to see improvement in your condition.

The dosage is based on your body weight and blood level of IgE antibody, as well as your medical condition and response to therapy. Contact your doctor if you have a significant change in body weight during treatment. Your dose may need to be adjusted.

Do not stop any of your asthma medications without consulting your doctor. Your condition may become worse if your asthma drugs are abruptly stopped. Any decrease of your medications (e.g., corticosteroids) should be done gradually, under the supervision of your doctor.

See also Warning section.

Injection site itching, redness, stinging, or pain may occur. Leg, arm or ear pain may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: unusual lumps/growths/moles.

An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, hives, itching/swelling (especially of the face/tongue/throat), dizziness, chest tightness, cough, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using omalizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: other medications for asthma.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

Do not share this medication with others.

Keep all medical appointments. Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store unopened vials in the refrigerator between 36 and 46 degrees F (2-8 degrees C). Once a vial is mixed, use the solution within 8 hours when stored in the refrigerator, or within 4 hours when stored at room temperature. Keep vials away from direct sunlight. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).

Information last revised October 2008 Copyright(c) 2008 First DataBank, Inc.