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 in adults and children who are at least 12 years old. It is not a rescue medicine for treating an asthma attack.
Xolair is also used to treat chronic hives (idiopathic urticaria) in adults and children who are at least 12 years old.
Xolair is usually given after other medicines have been tried without success.
Important information
Some people using Xolair have had a severe, life-threatening allergic reaction either right after the injection or hours later. Allergic reaction may occur even after using Xolair regularly for a year or longer.
Get emergency medical help if you have any of these signs of an allergic reaction to Xolair: 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 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 Xolair 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.
Before taking this medicine
You should not use Xolair if you are allergic to omalizumab.
To make sure Xolair is safe for you, tell your doctor if you have:
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any signs of infection (fever, swollen glands, general ill feeling);
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any other allergies (foods, pollens, etc);
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an infection caused by parasites (such as giardia, malaria, leishmaniasis, hookworm, pinworm, toxoplasmosis, and many others);
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past or present cancer;
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a history of heart attack or stroke;
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if you are receiving allergy shots; or
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if you have ever had a severe allergic reaction (anaphylaxis).
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.
It is not known whether omalizumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Do not give Xolair to a child younger than 12 years old.
How should I use Xolair?
Xolair is injected under the skin. A healthcare provider will give you this injection. Xolair is usually given every 2 or 4 weeks.
Your doctor may perform tests to make sure you do not have conditions that would prevent you from safely using Xolair.
You will be watched closely for a short time after receiving Xolair, to make sure you do not have an allergic reaction to the medication.
Your condition may be treated with a combination of 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 medicine, 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.
While using Xolair, 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.
Your condition may not improve right away. 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.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Xolair?
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 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:
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hives, rash;
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anxiety or fear, feeling like you might pass out;
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flushing (warmth, redness, or tingly feeling);
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chest tightness, wheezing, feeling short of breath, difficult breathing;
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fast or weak heartbeats; or
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swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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bronchospasm (wheezing, chest tightness, trouble breathing);
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fever, swollen glands, rash or itching, joint pain, or general ill feeling;
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chest pain spreading to your jaw or shoulder, coughing up blood;
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sudden numbness or weakness (especially on one side of the body), problems with vision or speech;
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pain, swelling, warmth, or redness in one or both legs;
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new or worsening cough, fever, trouble breathing; or
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skin rash, bruising, severe tingling, numbness, pain, muscle weakness.
Common Xolair side effects may include:
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itching, mild rash;
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joint pain, bone fractures;
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arm or leg pain;
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nausea;
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dizziness, tired feeling;
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ear pain; or
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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.
See also: Side effects (in more detail)
What other drugs will affect Xolair?
Other drugs may interact with omalizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
