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Neupogen (Filgrastim) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

NEUPOGEN drug label information in our database does not contain a dedicated section on drug interactions. Please check subsections of WARNINGS AND PRECAUTIONS as well as other sources.

OVERDOSAGE

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.

CONTRAINDICATIONS

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

REFERENCES

  1. Zsebo KM‚ Cohen AM‚ Murdock DC‚ et al. Recombinant human granulocyte colony-stimulating factor: Molecular and biological characterization. Immunobiol. 1986;172:175-184.
  2. Welte K‚ Bonilla MA‚ Gillio AP‚ et al. Recombinant human G-CSF: Effects on hematopoiesis in normal and cyclophosphamide treated primates. J Exp Med. 1987;165:941-948.
  3. Duhrsen U‚ Villeval JL‚ Boyd J‚ et al. Effects of recombinant human granulocyte colony-stimulating factor on hematopoietic progenitor cells in cancer patients. Blood. 1988;72:2074-2081.
  4. Souza LM‚ Boone TC‚ Gabrilove J‚ et al. Recombinant human granulocyte colony-stimulating factor: Effects on normal and leukemic myeloid cells. Science. 1986;232:61-65.
  5. Weisbart RH‚ Kacena A‚ Schuh A‚ Golde DW. GM-CSF induces human neutrophil IgA-mediated phagocytosis by an IgA Fc receptor activation mechanism. Nature. 1988;332:647-648.
  6. Kitagawa S‚ Yuo A‚ Souza LM‚ Saito M‚ Miura Y‚ Takaku F. Recombinant human granulocyte colony-stimulating factor enhances superoxide release in human granulocytes stimulated by chemotactic peptide. Biochem Biophys Res Commun. 1987;1443:1146.
  7. Glaspy JA‚ Baldwin GC‚ Robertson PA‚ et al. Therapy for neutropenia in hairy cell leukemia with recombinant human granulocyte colony-stimulating factor. Ann Int Med. 1988;109:789-795.
  8. Yuo A‚ Kitagawa S‚ Ohsaka A‚ et al. Recombinant human granulocyte colony-stimulating factor as an activator of human granulocytes: Potentiation of responses triggered by receptor-mediated agonists and stimulation of C3bi receptor expression and adherence. Blood. 1989;74:2144-2149.
  9. Gabrilove JL‚ Jakubowski A‚ Fain K‚ et al. Phase I study of granulocyte colony-stimulating factor in patients with transitional cell carcinoma of the urothelium. J Clin Invest. 1988;82:1454-1461.
  10. Morstyn G‚ Souza L‚ Keech J‚ et al. Effect of granulocyte colony-stimulating factor on neutropenia induced by cytotoxic chemotherapy. Lancet. 1988;1:667-672.
  11. Bronchud MH‚ Scarffe JH‚ Thatcher N‚ et al. Phase I/II study of recombinant human granulocyte colony-stimulating factor in patients receiving intensive chemotherapy for small cell lung cancer. Br J Cancer. 1987;56:809-813.
  12. Gabrilove JL‚ Jakubowski A‚ Scher H‚ et al. Effect of granulocyte colony-stimulating factor on neutropenia and associated morbidity due to chemotherapy for transitional cell carcinoma of the urothelium. N Engl J Med. 1988;318:1414-1422.
  13. Neidhart J‚ Mangalik A‚ Kohler W‚ et al. Granulocyte colony-stimulating factor stimulates recovery of granulocytes in patients receiving dose-intensive chemotherapy without bone-marrow transplantation. J Clin Oncol. 1989;7:1685-1691.
  14. Bronchud MH‚ Howell A‚ Crowther D‚ et al. The use of granulocyte colony-stimulating factor to increase the intensity of treatment with doxorubicin in patients with advanced breast and ovarian cancer. Br J Cancer. 1989;60:121-128.
  15. Heil G, Hoelzer D, Sanz MA, et al. A randomized, double-blind, placebo-controlled, phase III study of Filgrastim in remission induction and consolidation therapy for adults with de novo Acute Myeloid Leukemia. Blood. 1997;90:4710-4718.
  16. Dale DC‚ Bonilla MA‚ Davis MW‚ et al. A randomized controlled phase III trial of recombinant human granulocyte colony-stimulating factor (Filgrastim) for treatment of severe chronic neutropenia. Blood. 1993;81:2496-2502.
  17. Schroeder TM and Kurth R. Spontaneous chromosomal breakage and high incidence of leukemia in inherited disease. Blood. 1971;37:96-112.
  18. Medlock ES, Kaplan DL, Cecchini M, Ulich TR, del Castillo J, Andresen J. Granulocyte colony-stimulating factor crosses the placenta and stimulates fetal rat granulopoiesis. Blood. 1993;81:916-922.
  19. Calhoun DA, Rosa C, Christensen RD. Transplacental passage of recombinant human granulocyte colony-stimulating factor in women with an imminent preterm delivery. Am J Obstet Gynecol. 1996;174:1306-1311.

This product and its use are covered by the following US Patent Nos.: 4,810,643; 4,999,291; 5,582,823; 5,580,755.

[AMGEN LOGO]

Manufactured by:

Amgen Manufacturing, Limited,

a subsidiary of Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799

3xxxxxx

© 1991-2007 Amgen Inc. All rights reserved.

v.20.2 - Issue Date: 09/2007

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