Generic Name: omalizumab (OH ma LIZ oo mab)
Brand Names: Xolair

What is Xolair?

Xolair (omalizumab) is an antibody that helps decrease allergic responses in the body.

Xolair is used to treat moderate to severe asthma that is caused by allergies, and chronic idiopathic urticaria (a form of chronic hives) in adults and children who are at least 12 years old.

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

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

Important information

Some people using Xolair 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 to Xolair: 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.

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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 a 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 Xolair. 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.

Use Xolair regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Using Xolair 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.

Before using Xolair

Do not use Xolair if you are allergic to omalizumab.

To make sure you can safely take Xolair, tell your doctor if you have any other medical conditions or if you take other medicines.

Using Xolair 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 Xolair, 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.

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

See also: Pregnancy and breastfeeding warnings (in more detail)

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Xolair on the baby.

Omalizumab may pass into breast milk and could harm a nursing baby. Do not use Xolair without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 12 years old.

How should I use Xolair?

Xolair is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Xolair is usually given every 2 or 4 weeks.

Xolair is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Xolair will not work fast enough to treat an asthma attack that has already begun. Use only a fast-acting inhalation medicine to treat an asthma attack.

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 a steroid medication, do not stop using it 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 Xolair. 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.

Use Xolair regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure Xolair is helping your condition, your doctor may want you to have allergy tests and lung function tests on a regular basis. Do not miss any scheduled visits to your doctor.

Store Xolair in the refrigerator. Do not freeze. After mixing Xolair with a diluent, store in the refrigerator and use it within 8 hours. Do not freeze. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

What happens if I miss a dose?

Contact your doctor if you miss a dose of Xolair.

What happens if I overdose?

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

What should I avoid?

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

Xolair side effects

Some people using Xolair have had a severe, life-threatening allergic reaction to Xolair, 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, numbness, or unusual weakness.

Less serious Xolair side effects may include:

  • pain;

  • headache, 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.

See also: Side effects (in more detail)

What other drugs will affect Xolair?

Before using Xolair, tell your doctor if you are receiving allergy shots.

There may be other drugs that can interact with Xolair. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Xolair.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Xolair only for the indication prescribed.
  • 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 1996-2014 Cerner Multum, Inc. Version: 3.02. Revision Date: 10/04/2010 1:46:42 PM.

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