Common side effects
Commonly reported side effects that occurred in clinical studies with Amevive (for the treatment of moderate-to-severe psoriasis) included sore throat, dizziness, cough, nausea, itching, muscle aches,
chills, injection site reactions, and accidental injury.[1] These side effects didn’t stop patients from receiving treatment.
Serious side effects
Also, there was a low incidence of serious side effects in clinical trials which did not increase with an additional course of Amevive. Some
patients who received Amevive in clinical studies were found to have cancers. Most of these cases were skin cancers. There were also other types
of cancer and lymphomas. Some patients developed serious infections, including wound infections and pneumonia.[1,2]
Remember to always discuss any side effects you experience with your doctor.
Amevive is approved for the treatment of moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Additional Safety Information
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Amevive reduces the number of certain T cells. That is part of how it is thought to treat psoriasis. This reduction could increase the
possibility of getting an infection or cancer. Before taking Amevive, be sure to tell your doctor if you have had a serious infection or
cancer. Amevive should not be taken if you are HIV positive.
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Because Amevive reduces the number of T cells, you should have a blood test every 2 weeks during the dosing period to check your T-cell
levels. If your T-cell levels are too low, your doctor will check your blood weekly and will either postpone or stop treatment with Amevive.
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During and after taking Amevive, if you notice anything unusual about your health or any signs of infections such
as swollen glands, fever, or chills, notify your doctor right away.
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Amevive should not be taken if you are known to be allergic to Amevive or any of its components, since serious
allergic reactions such as hives, with or without swelling of the mouth and tongue, have been seen.
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Some patients treated with Amevive have had serious liver injury. If your skin or the whites of your eyes become yellow, if you start to
bruise easily, or if you have persistent loss of appetite or vomiting, you should call your doctor right away.
If you become pregnant during treatment with Amevive, tell your doctor and consider enrolling in the Pregnancy Registry by calling 1-866-834-7223.
Information collected in this program is kept confidential.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
fda.gov/medwatch or
call 1-800-FDA-1088.
Please see the full prescribing information and talk to your
doctor for more information.
References
- 1. Amevive® (alefacept) prescribing information, Astellas Pharma US, Inc.
- 2. Goffe B, Papp K, Gratton D, et al. An integrated analysis of thirteen trials summarizing the long-term safety
of alefacept in psoriasis patients who have received up to nine courses of therapy. Clin Ther. 2005;27:1912-1921.