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|Efalizumab

EFALIZUMAB (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Raptiva

† Not commercially available in Canada.

Category

• Antipsoriatic
• Immunosuppressant

Description

Efalizumab (e-fa-li-ZOO-mab) is used in adult patients to treat moderate to severe psoriasis.

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

• Parenteral
• Subcutaneous injection (U.S.)

Before Using This Medicine

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

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

Pregnancy—Efalizumab has not been studied in pregnant women. Efalizumab has not been shown to cause birth defects or other problems in animal studies. Efalizumab should be used with caution in pregnant women and should be used only if clearly needed. Discuss this with your doctor.

Breast-feeding—It is not known whether efalizumab passes into breast milk. However, in animals efalizumab has been shown to cause adverse effects in nursing babies. It may be necessary for you to take another medicine or stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of efalizumab in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people and it may not be known if they work the same way they do in younger adults. Elderly people may have more age-related problems than younger people and may need less of this medicine.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking efalizumab, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Immunosuppressive agents (medicines used to lower the body"s natural immunity)—These can cause your immune system to be weakened and should not be used at the same time as efalizumab.

Other medical problems—The presence of other medical problems may affect the use of efalizumab. Make sure you tell your doctor if you have any other medical problems, especially:

• Cancer, history of—This medicine should not be used in patients with a history of cancer and it should be used with caution in patients at risk for cancer

• Infection, moderate to severe—Efalizumab could make your infection worse; your doctor may want to stop this medicine if you get an infection

• Thrombocytopenia (not enough platelets in your blood)—May give you a higher chance for bleeding; your doctor may want to stop this medicine if you have a low platelet count

Proper Use of This Medicine

Dosing—The dose of efalizumab will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of efalizumab. If your dose is different, do not change it unless your doctor tells you to do so.

• For parenteral dosage form
  • Psoriasis
    • Adults—The dose is based on your body weight and must be determined by your doctor. This medicine is injected under your skin of your upper leg (thigh), upper arm, abdomen or buttocks once a week. Change (rotate) your skin injection site with each injection.
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose, contact your healthcare provider to find out when to take your next dose of efalizumab and what schedule to follow after that.

Storage—To store this medicine:

• Keep out of the reach of children.
• Protect from light.
• Store in the refrigerator. However, keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check you at regular visits for any blood problems or any other side effects that may be caused by this medicine.

While you are being treated with efalizumab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor"s approval. Efalizumab may lower your body"s resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, the other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also avoid persons who have recently taken oral polio vaccine. Do not get close to them or stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective mask that covers the nose and mouth.

It is important to check with your doctor if you have any symptoms of an infection such as fever or chills, cough or hoarseness, lower back or side pain, painful or difficult urination. If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Check with you doctor immediately if you notice an unusual bleeding or busing, black, tarry stools, blood in urine, or stools, or pinpoint red spots on your skin

It is important to tell your doctor if you become pregnant. Your doctor may want you join a pregnancy registry for patients taking this medicine.

Side Effects of This Medicine

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.

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

Developed: 10/13/2004

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