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Alefacept Side Effects

For the Consumer

Applies to alefacept: intramuscular powder for solution

Along with its needed effects, alefacept 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 or nurse immediately if any of the following side effects occur while taking alefacept:

More common
  • Chills
  • cough
  • fever
  • hoarseness
  • lower back or side pain
  • painful or difficult urination
Less common
  • Body aches or pain
  • congestion
  • dryness or soreness of the throat
  • runny nose
  • tender, swollen glands in the neck
  • trouble with swallowing
  • voice changes
  • Arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • fast or irregular heartbeat
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • shortness of breath
  • sweating
  • vomiting

Some side effects of alefacept may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Pain, swelling, bleeding, skin rash, or lumps at the injection site
Less common
  • Difficulty with moving
  • dizziness
  • itching skin
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • swollen joints
  • Headache

For Healthcare Professionals

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


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


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

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


Twenty five of the 1,357 patients who received alefacept 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.[Ref]

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


Chills have been reported to occur predominantly with intravenous administration.[Ref]

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.[Ref]


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


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


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


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


Musculoskeletal side effects including myalgia have been reported.[Ref]


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


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


1. "Product Information. Amevive (alefacept)." Biogen, Cambridge, MA.

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.