Amevive Side Effects

Generic name: alefacept

Note: This document contains side effect information about alefacept. Some of the dosage forms listed on this page may not apply to the brand name Amevive.

Some side effects of Amevive may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to alefacept: intramuscular powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking alefacept (the active ingredient contained in Amevive) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using alefacept and call your doctor at once if you have a serious side effect such as:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• swelling, warmth, redness, itching, or oozing from the skin;

• new skin lesions, or a sunburn-like skin rash; or

• worsening or no improvement of your skin condition.

Less serious side effects of alefacept may include:

• sore throat, cough;

• dizziness;

• mild nausea;

• headache;

• itching;

• muscle pain;

• pain or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to alefacept: intramuscular powder for injection, intravenous powder for injection

Immunologic

Immunologic side effects including dose-dependent reductions in circulating CD4+ and CD8+ T lymphocyte counts have been reported.

Cardiovascular

The total percentage of alefacept-treated patients hospitalized for cardiovascular events was 1.2%.

Cardiovascular side effects including coronary artery disorder (<1%) and myocardial infarction (<1%) have been the adverse reactions which most commonly resulted in clinical intervention.

Oncologic

Twenty five of the 1,357 patients who received alefacept (the active ingredient contained in Amevive) were diagnosed with a total of 35 treatment-emergent malignancies. Six cases were basal cell and seventeen cases were squamous cell cancers of the skin. Three cases of lymphoma have been reported; one was classified as non-Hodgkin's follicle-center cell lymphoma and two were classified as Hodgkin's disease.

Oncologic side effects including malignancies have been reported. Postmarketing reports of malignancies including skin, solid organ, lymphomas and leukemias have also been received.

General

Chills have been reported to occur predominantly with intravenous administration.

General side effects including chills (6%), dizziness, headache, and accidental injury have been reported. Postmarketing reports of sepsis and opportunistic infections (viral, fungal, and bacterial) have been received.

Local

Local side effects including injection site pain and injection site inflammation have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea have been reported. Postmarketing reports of clostridium difficile colitis have been received.

Respiratory

Respiratory side effects including pharyngitis and increased cough have been reported. Postmarketing reports of pharyngitis have also been received.

Dermatologic

Dermatologic side effects including pruritus have been reported. Postmarketing reports of cellulitis have been received.

Musculoskeletal

Musculoskeletal side effects including myalgia have been reported.

Hepatic

Hepatic side effects including postmarketing reports of asymptomatic transaminase elevation, fatty infiltration of the liver, hepatitis, and severe liver failure have been received.

Genitourinary

Genitourinary side effects including postmarketing reports of urinary tract infection have been received.

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