Amevive« (Alefacept) - A - Detailing from Skin Therapy Letter

 

Amevive« (Alefacept)

 

 

  Content:

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/ÁL . The drug should be discontinued if the count stays below 250 cells/ÁL for longer than a month
  • Only 4% of patients had a CD4 count below 250 cells/ÁL (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/ÁL

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