"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
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.
Last reviewed on RxList: 6/4/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Neupogen Information
Neupogen - User Reviews
Neupogen User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
Get the latest treatment options.