Procrit - Clinical Pharmacology

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In normal volunteers, the half-life of intravenously administered PROCRIT is approximately 20% shorter than the half-life in CRF patients. The pharmacokinetics of PROCRIT have not been studied in HIV-infected patients. The pharmacokinetic profile of Epoetin alfa in children and adolescents appears to be similar to that of adults. Limited data are available in neonates. 17 It has been demonstrated in normal volunteers that the 10,000 U/ mL citrate-buffered Epoetin alfa formulation and the 40,000 U/ mL phosphate-buffered Epoetin alfa formulation are bioequivalent after subcutaneous administration of single 750 Units/ kg doses.

The Cmax and t1/ 2 after administration of the phosphate buffered Epoetin alfa formulation were 1.80 ± 0.7 U/ 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 U/ mL and 16.3 ± 3. 0 hours. There was minimal accumulation in serum after two weekly 750 Units/ kg subcutaneous doses of Epoetin alfa.