Pronunciation: OH ma LIZ oo mab

Brand: Xolair

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

Some people using omalizumab 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 signs of an allergic reaction: 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.

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 in adults and children who are at least 6 years old. Omalizumab 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 also 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 may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using omalizumab?

You should not use omalizumab if you are allergic to it.

To make sure omalizumab is safe for you, tell your doctor if you have:

  • any signs of infection (fever, swollen glands, general ill feeling);
  • any other allergies (foods, pollens, etc);
  • an infection caused by parasites (such as giardia, malaria, leishmaniasis, hookworm, pinworm, toxoplasmosis, and many others);
  • past or present cancer;
  • a history of heart attack or stroke;
  • if you are receiving allergy shots; or
  • if you have ever had a severe allergic reaction (anaphylaxis).

Using this medicine 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.

Omalizumab is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

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 omalizumab 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 omalizumab to a child younger than 12 years old.

How should I use omalizumab?

Before you start treatment with omalizumab, your doctor may perform an allergy skin test or blood test to make sure this medicine is right for you.

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

You will be watched closely for a short time after receiving omalizumab, 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 omalizumab, 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 omalizumab 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 omalizumab?

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

What are the possible side effects of omalizumab?

Some people using omalizumab 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 signs of an allergic reaction:

  • hives, rash;
  • anxiety or fear, feeling like you might pass out;
  • flushing (warmth, redness, or tingly feeling);
  • chest tightness, wheezing, 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:

  • bronchospasm (wheezing, chest tightness, trouble breathing);
  • fever, swollen glands, rash or itching, joint pain, or general ill feeling;
  • chest pain spreading to your jaw or shoulder, coughing up blood;
  • sudden numbness or weakness (especially on one side of the body), problems with vision or speech;
  • pain, swelling, warmth, or redness in one or both legs;
  • new or worsening cough, fever, trouble breathing; or
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness.

Common side effects may include:

  • itching, mild rash;
  • joint pain, bone fractures;
  • arm or leg pain;
  • nausea;
  • dizziness, tired feeling;
  • ear pain; 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.

What other drugs will affect omalizumab?

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about omalizumab.

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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