Epogen - Clinical Pharmacology

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In normal volunteers, the half-life of IV administered EPOGEN (r) is approximately 20% shorter than the half-life in CRF patients. The pharmacokinetics of EPOGEN (r) have not been studied in HIV-infected patients.

The pharmacokinetic profile of EPOGEN (r) in children and adolescents appears to be similar to that of adults. Limited data are available in neonates. It has been demonstrated in normal volunteers that the 10,000 Units/ mL citrate-buffered Epoetin alfa formulation and the 40,000 Units/ mL phosphate-buffered Epoetin alfa formulation are bioequivalent after SC administration of single 750 Units/ kg doses.

The Cmax and t1/ 2 after administration of the phosphate buffered Epoetin alfa formulation were 1.8 ± 0.7 Units/ mL and 19.0 ± 5.9 hours (mean ± SD), respectively. The corresponding mean ± SD values for the citrate-buffered Epoetin alfa formulation were 2 ± 0.9 Units/ mL and 16.3 ± 3. 0 hours. There was no notable accumulation in serum after two weekly 750 Units/ kg SC doses of Epoetin alfa.