Epogen

[Epoetin alfa]

The rate of hematocrit increase varies between patients and is dependent upon the dose of EPOGEN (r) , within a therapeutic range of approximately 50 to 300 Units/ kg TIW. 4 A greater biologic response is not observed at doses exceeding 300 Units/ kg TIW. 6 Other factors affecting the rate and extent of response include availability of iron stores, the baseline hematocrit, and the presence of concurrent medical problems.

Zidovudine-treated HIV-infected Patients

Responsiveness to EPOGEN (r) in HIV-infected patients is dependent upon the endogenous serum erythropoietin level prior to treatment. Patients with endogenous serum erythropoietin levels 500 mUnits/ mL, and who are receiving a dose of zidovudine 4200 mg/ week, may respond to EPOGEN (r) therapy. Patients with endogenous serum erythropoietin levels > 500 mUnits/ mL do not appear to respond to EPOGEN (r) therapy. In a series of four clinical trials involving 255 patients, 60% to 80% of HIV-infected patients treated with zidovudine had endogenous serum erythropoietin levels 500 mUnits/ mL.

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Response to EPOGEN (r) in zidovudine-treated HIV-infected patients is manifested by reduced transfusion requirements and increased hematocrit.

Cancer Patients on Chemotherapy

Anemia in cancer patients may be related to the disease itself or the effect of concomitantly administered chemotherapeutic agents. EPOGEN (r) has been shown to increase hematocrit and decrease transfusion requirements after the first month of therapy (months 2 and 3), in anemic cancer patients undergoing chemotherapy. A series of clinical trials enrolled 131 anemic cancer patients who were receiving cyclic cisplatin-or non cisplatin-containing chemotherapy. Endogenous baseline serum erythropoietin levels varied among patients in these trials with approximate-ly 75% (n = 83/ 110) having endogenous serum erythropoietin levels 132 mUnits/ mL, and approximately 4% (n = 4/ 110) of patients having endogenous serum erythropoietin levels > 500 mUnits/ mL.

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