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Generic Name: alefacept (a-LEF-a-sept)
Brand Name: Amevive

Alefacept is used for:

Treating moderate to severe psoriasis.

Alefacept is an immunosuppressant. It works by decreasing the activity of immune cells and decreasing the rate of skin cell multiplication.

Do NOT use alefacept if:

  • you are allergic to any ingredient in alefacept
  • you have HIV
  • you are taking a medicine that can suppress your immune system (eg, cancer chemotherapy, prednisone, cyclosporine) or receiving phototherapy

Contact your doctor or health care provider right away if any of these apply to you.

Before using alefacept:

Some medical conditions may interact with alefacept. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have an infection (eg, pneumonia, skin infection, tuberculosis) or have a history of infections that keep coming back
  • if you have a history of cancer or an immune system disorder (immunosuppression)
  • if you have liver problems, herpes, or syphilis
  • if you have or are at high risk of developing tumors
  • if you are scheduled to receive a vaccination
  • if you drink alcohol

Some MEDICINES MAY INTERACT with alefacept. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Medicine that can suppress your immune system (eg, chemotherapy, prednisone, methotrexate, cyclosporine) or phototherapy because too much immune system suppression may occur, increasing risk of side effects including risk of infection

This may not be a complete list of all interactions that may occur. Ask your health care provider if alefacept may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use alefacept:

Use alefacept as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Alefacept comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get alefacept refilled.
  • Alefacept is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using alefacept at home, a health care provider will teach you how to use it. Be sure you understand how to use alefacept. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Alefacept is given by intramuscular (IM) injection once weekly. Plan your injection on the same day each week to help you remember to administer it.
  • Do not shake alefacept. This will prevent foaming of the medicine.
  • Alefacept should be clear and colorless to slightly yellow. If alefacept contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • Rotate injection sites. Each injection should be given at least 1 inch from an old site. An injection should not be given into an area of skin that is sore, bruised, red, or hard.
  • Use alefacept on a regular schedule to get the most benefit from it.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
  • If you miss a dose of alefacept, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use alefacept.

Important safety information:

  • Alefacept may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use alefacept with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not receive a live vaccine (eg, measles, mumps) while you are using alefacept. Talk with your doctor before you receive any vaccine.
  • Carry an ID card at all times that says you take alefacept.
  • Alefacept may lower the ability of your body to fight infection. Serious infections have been reported in patients using alefacept. Avoid contact with people who have colds or infections. Tell your doctor right away if you notice signs of infection (eg, fever; chills; persistent cough or sore throat; swollen glands; blood in the phlegm; burning, difficult, frequent, or painful urination; warm, red, or painful skin; sores on the body; muscle aches; severe or persistent diarrhea or stomach pain; shortness of breath; unusual sweating; unusual tiredness).
  • Alefacept may increase your risk of developing cancer. Tell your doctor if you have ever had cancer. Contact your doctor if you notice a change in the appearance or size of a mole, new skin growths, unusual lumps, night sweats, unusual tiredness or weakness, loss of appetite, or unusual weight loss. Discuss any questions or concerns with your doctor.
  • Lab tests, including white blood cell counts, may be performed while you use alefacept. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use alefacept with caution in the ELDERLY; they may be more sensitive to its effects.
  • Alefacept is not approved for use in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using alefacept while you are pregnant. Notify your doctor if you become pregnant while using alefacept or within 8 weeks after stopping treatment. It is not known if this medicine is found in breast milk. Do not breast-feed while taking alefacept.

Possible side effects of alefacept:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; increased cough; mild pain, redness, or swelling at the injection site; mild sore throat; muscle aches or pain; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blood in the phlegm; burning, difficult, frequent, or painful urination; change in the appearance or size of a mole; chest pain; fever, chills, or persistent cough or sore throat; loss of appetite; new skin growths; night sweats; severe or persistent diarrhea or stomach pain; shortness of breath; sores on the body; swollen glands; symptoms of liver problems (eg, dark urine, easy bruising, pale stools, persistent loss of appetite or vomiting, stomach pain, yellowing of the skin or eyes); unusual lumps; unusual sweating; unusual tiredness or weakness; unusual vaginal discharge; unusual weight loss; warm, red, or painful skin; white patches in the mouth (oral thrush).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chills; headache; joint pain.

Proper storage of alefacept:

Alefacept is usually handled and stored by a health care provider. If you are using alefacept at home, store alefacept as directed by your pharmacist or health care provider. Keep alefacept out of the reach of children and away from pets.

General information:

  • If you have any questions about alefacept, please talk with your doctor, pharmacist, or other health care provider.
  • Alefacept is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take alefacept or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about alefacept. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to alefacept. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using alefacept.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.