Epogen

[Epoetin alfa]

Zidovudine-treated HIV-infected Patients

Adverse events reported in clinical trials with EPOGEN (r) in zidovudine-treated HIV-infected patients were consistent with the progression of HIV infection. In double-blind, placebo-controlled studies of 3 months duration involving approxi-mately 300 zidovudine-treated HIV-infected patients, adverse events with an incidence of 10% in either patients treated with EPOGEN (r) or placebo-treated patients were:

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There were no statistically significant differences between treatment groups in the incidence of the above events. In the 297 patients studied, EPOGEN (r) was not associated with significant increases in opportunistic infections or mortality. 25 In 71 patients from this group treated with EPOGEN (r) at 150 Units/ kg TIW, serum p24 antigen levels did not appear to increase. Preliminary data showed no enhancement of HIV replication in infected cell lines in vitro. 25 Peripheral white blood cell and platelet counts are unchanged following
EPOGEN (r) therapy.

Allergic Reactions

Two zidovudine-treated HIV-infected patients had urticarial reactions within 48 hours of their first exposure to study medication. One patient was treated with EPOGEN (r) and one was treated with placebo (EPOGEN (r) vehicle alone). Both patients had positive immediate skin tests against their study medication with a negative saline control. The basis for this apparent pre-existing hypersensitivity to components of the EPOGEN (r) formula-tion is unknown, but may be related to HIV-induced immunosuppression or prior exposure to blood products.

300 Units/ kg daily x 15), 4 subjects in the 600 Units/ kg weekly EPOGEN (r) group (5%) and no subjects in the 300 Units/ kg daily group had a thrombotic vascular event during the study period. In a study examining the use of Epoetin alfa in 182 patients scheduled for coro-nary artery bypass graft surgery, 23% of patients treated with Epoetin alfa and 29% treated with placebo experienced thrombotic/ vascular events. There were 4 deaths among the Epoetin alfa-treated patients that were associated with a throm-botic/ vascular event. A causative role of Epoetin alfa cannot be excluded (see WARNINGS).

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