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

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. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

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

It is important to 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.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is omalizumab?

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.

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

Omalizumab may also be used for purposes other than those listed in this medication guide.

Precautions

Do not use this medication if you are allergic to omalizumab.

Before using omalizumab, tell your doctor if you have any other medical conditions or if you take other medicines.

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.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on a pregnancy registry if you become pregnant while you are using this medication or within 8 weeks after receiving at least one dose of omalizumab. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether omalizumab had any effect on the baby.

Omalizumab may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using omalizumab.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of omalizumab is not likely to produce life-threatening symptoms.

Contact your doctor if you miss a dose of omalizumab.

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Side Effects

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, or unusual weakness.

Less serious side effects may be more likely to occur, such as:

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

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Interactions

There may be other drugs that can affect omalizumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04