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Omalizumab (Systemic)


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Omalizumab (Systemic)

US Brand Names

• Xolair

Description

Omalizumab ((oh-mah-lye-ZOO-mab)) is used to treat moderate to severe persistent allergic asthma. Omalizumab is a shot (injection) given under the skin (subcutaneous) The shot is given every 2 or 4 weeks. For many patients who still have asthma symptoms even though they are taking inhaled steroids, omalizumab helps to reduce the number of asthma attacks.

Omalizumab is a medicine called an IgE blocker. IgE is short for immunoglobulin E. IgE is a substance that occurs naturally in the body in small amounts. This substance plays an important role in allergic asthma. When people with allergic asthma breathe in a year-round allergen, such as cat or dog dander, their bodies make more IgE. This may cause a series of reactions in your body that can lead to asthma attacks and symptoms. Omalizumab works by helping to block IgE.

This medicine is available only with your doctor's prescription, in the following dosage forms:

    Parenteral

    • Injection (U.S.)

Special Considerations

In deciding to use a medicine, the risks of taking using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For omalizumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to omalizumab. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy

Omalizumab has not been studied in pregnant women. However, omalizumab has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding

It is not known whether omalizumab passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast feeding. Mothers who are using this medicine and wish to breast feed should discuss this with their doctor.

Children

Although there is no specific information comparing the use of omalizumab in children with other age groups, this medicine is not expected to cause different side effects or problems in children than it does in older adults. This medicine can be used in children 12 years of age and older.

Older adults

Many medicines have not been specifically studied in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of omalizumab in the elderly with use in other age groups.

Other medicines

Omalizumab is approved for use in patients who are already taking inhaled steroids. As with all medicines, be sure to tell your doctor about any medicines you are taking for your asthma or any other condition. This includes prescription and nonprescription medicines, vitamins, and herbal supplements.

Administration

Dosing

The dose of omalizumab will be different for different patients. The following information includes only the average doses of omalizumab.

You will receive omalizumab once every 2 or 4 weeks. Your dose will be determined by your IgE level, which your doctor will measure with a simple blood test before treatment begins, and your body weight. Based on your dose, your doctor will also tell you if you will need 1, 2, or 3 injections per dose. If you need more than 1 injection, each will be given in a different place on your body.

Omalizumab is not a rescue medication and should not be used to treat sudden asthma attacks. It is not a substitute for the medicines you are already taking. Never suddenly stop taking, or change the dose of, your inhaled steroids or any other asthma medicine you are taking unless your doctor tells you to do so.

    • For parenteral dosage form (injection):

      o For allergic asthma:

        Adults-150 to 375 milligrams (mg) is administered by a shot (injection) under the skin every 2 or 4 weeks

        Children-Use and dose for children under 12 years of age must be determined by your doctor.

Precautions

If you stop receiving omalizumab injections, your symptoms can be expected to return.

You may not see immediate improvement in your asthma after omalizumab treatment begins. It takes time for the medicine to work. So if you don't feel a difference right away, it doesn't mean omalizumab is not working. It is important to continue your omalizumab injections until your doctor tells you otherwise.

It is important to know the signs of an allergic reaction to this medicine and to know what to do. Get medical help immediately if you have any symptoms such as rash, itching, and swelling of the tongue and throat.

Your doctor will ask you to remain at the healthcare facility or clinic for a period of time after each injection to watch for immediate side effects that can be serious.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Cough; difficulty swallowing; dizziness; fast heartbeat; hives; itching; malignant tumor; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; shortness of breath; skin rash; tightness in chest; unusual tiredness or weakness; wheezing.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

More Common

Bleeding; blistering; body aches or pain; burning; chills; cold or flu-like symptoms; coldness; congestion; discoloration of skin; dryness or soreness of throat; feeling of pressure; fever; headache; hoarseness; infection; inflammation; itching; leg pain; lumps; muscle or joint pain; numbness; pain; pain or tenderness around eyes and cheekbones; redness; runny nose; scarring; shortness of breath or troubled breathing; sore throat; soreness; stinging; stuffy or runny nose; swelling; tender, swollen glands in neck; tenderness; tingling; trouble in swallowing; ulceration; voice changes; warmth.

Less common or uncommon

Arm pain; blistering, crusting, irritation, itching, or reddening of skim; body produces substance that can bind to drug making it less effective or cause side effects; cracked, dry, scaly skin; earache; itching skin.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

April 07, 2004

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