In cancer patients receiving NEUPOGEN® as an adjunct to myelosuppressive chemotherapy‚ it is recommended‚ to avoid the potential risks of excessive leukocytosis‚ that NEUPOGEN® therapy be discontinued if the ANC surpasses 10‚000/mm³ after the chemotherapy-induced ANC nadir has occurred. Doses of NEUPOGEN® that increase the ANC beyond 10‚000/mm³ may not result in any additional clinical benefit.

The maximum tolerated dose of NEUPOGEN® has not been determined. Efficacy was demonstrated at doses of 4 to 8 mcg/kg/day in the phase 3 study of nonmyeloablative chemotherapy. Patients in the BMT studies received up to 138 mcg/kg/day without toxic effects‚ although there was a flattening of the dose response curve above daily doses of greater than 10 mcg/kg/day.

In NEUPOGEN® clinical trials of cancer patients receiving myelosuppressive chemotherapy‚ WBC counts > 100‚000/mm³ have been reported in less than 5% of patients‚ but were not associated with any reported adverse clinical effects.

In cancer patients receiving myelosuppressive chemotherapy‚ discontinuation of NEUPOGEN® therapy usually results in a 50% decrease in circulating neutrophils within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7 days.

NEUPOGEN® is contraindicated in patients with known hypersensitivity to E coli-derived proteins‚ Filgrastim‚ or any component of the product.

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