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|Amevive

ALEFACEPT (Systemic)

Some commonly used brand names are:

In the U.S.—

• Amevive

In Canada—

• Amevive

Category

• Antipsoriatic
• Immunosuppressant

Description

Alefacept( (a-LE-fa-sept)) is used in adult patients to treat moderate to severe psoriasis. This medicine is for patients who have used other medicines that have not worked for their psoriasis.

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

• Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

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

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

Pregnancy—Alefacept has not been studied in pregnant women. Alefacept has not been shown to cause birth defects or other problems in animal studies. Alefacept 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 alefacept passes into breast milk. Mothers who are taking this medicine and wish to breast feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of alefacept 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 alefacept 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) or
• Phototherapy (use of light for therapy)—These can cause your immune system to be weakened and should not be used at the same time as alefacept.

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. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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

• Human immunodeficiency virus (HIV) infection—This medicine should not be used in patients who have HIV infection.

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

• Lymphopenia (small amount of white blood cells)—This medicine could make this condition worse; your doctor may want to stop this medicine if your white blood cell counts are too low.

• 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.

Proper Use of This Medicine

Dosing—The dose of alefacept may be different for different patients. Alefacept is usually given by a doctor or nurse. The following information includes only the average dose of alefacept.

• For parenteral dosage form
  • Psoriasis
    • Adults— 15 milligrams (mg) injected into a muscle once a week for 12 weeks
      — 7.5 milligrams (mg) injected into a vein once a week for 12 weeks
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Protect from light.
• Store this medicine at room temperature. Do not refrigerate.
• 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.

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.

You should contact your doctor right away if you develop persistent nausea, anorexia, fatigue, vomiting, abdominal pain, jaundice (yellow eyes and/or skin), easy bruising, dark urine, or pale stools.

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: 12/04/2003
Revised: 11/16/2005

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