Amevive Side Effects
Generic Name: alefacept
Note: This page contains information about the side effects of alefacept. Some of the dosage forms included on this document may not apply to the brand name Amevive.
Not all side effects for Amevive may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to alefacept: intramuscular powder for solution
In addition to its needed effects, some unwanted effects may be caused by alefacept (the active ingredient contained in Amevive). In the event that any of these side effects do occur, they may require medical attention.
If any of the following side effects occur while taking alefacept, check with your doctor or nurse immediately:More common
- lower back or side pain
- painful or difficult urination
- Body aches or pain
- 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
- pain or discomfort in the arms, jaw, back, or neck
- shortness of breath
Some of the side effects that can occur with alefacept may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- Pain, swelling, bleeding, skin rash, or lumps at the injection site
- Difficulty with moving
- itching skin
- joint pain
- muscle aching or cramping
- muscle pains or stiffness
- swollen joints
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 (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.[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.
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