Amevive^® (Alefacept)

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SIDE EFFECTS, SAFETY AND RISKS

• Well tolerated with excellent safety profile
• No evidence of increased risk of infection
• No opportunistic infections have been observed
• No evidence regarding increased risk of cancer. Psoriasis itself may have an increased risk of malignancy. [Arch Derm 2001;137:778-783. J Invest Dermatol 2000;114:587-590]
• No cumulative toxicity
• Combining the Alefacept with with UV light, systemic agents and topical therapy has been well tolerated in clinical trials and in practice
• No rebound or flare-up reported
• No immediate or late hypersensitivity reactions reported

Adverse reactions:

• In clinical trials, adverse events overall were similar to placebo after one courses of therapy and did not increase with subsequent courses of Alefacept (up to 8 courses to date).

Laboratory monitoring

• Bi-weekly CD4 T lymphocytes counts to guide dosing (monthly in new clinical trials)
• Withhold drug if CD4 below 250 cells/µL . The drug should be discontinued if the count stays below 250 cells/µL for longer than a month
• Only 4% of patients had a CD4 count below 250 cells/µL (in clinical trials) and no patients had to permanently discontinue treatment due to low CD4. No increased rate of infections in patients with a CD4 count below 250 cells/µL

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