Filgrastim (1 brand name, 2 dosage forms, 0 routes)
Available dosage forms: VIAL, SYRINGE.
Brand Names
- NEUPOGEN
Contraindications
NEUPOGEN is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim [see Warnings and Precautions (5.3)].
Adverse Reactions
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions (5.1)] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2)] Serious Allergic Reactions [see Warnings and Precautions (5.3)] Sickle Cell Disorders [see Warnings and Precautions (5.4)] Glomerulonephritis [see Warnings and Precautions (5.5)] Alveolar Hemorrhage and Hemoptysis [see Warnings and Precautions (5.6)] Capillary Leak Syndrome [see Warnings and Precautions (5.7)] Myelodysplastic Syndrome [see Warnings and Precautions (5.8)] Acute Myeloid Leukemia [see Warnings and Precautions (5.8)] Thrombocytopenia [see Warnings and Precautions (5.9)] Leukocytosis [see Warnings and Precautions (5.10)] Cutaneous Vasculitis [see Warnings and Precautions (5.11)] Aortitis [see Warnings and Precautions (5.15)]
Mechanism of Action
Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation‚ differentiation commitment‚ and some end-cell functional activation. Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes‚ fibroblasts, and endothelial cells. G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation‚ differentiation, and selected end-cell functions (including enhanced phagocytic ability‚ priming of the cellular metabolism associated with respiratory burst‚ antibody-dependent killing, and the increased expression of some cell surface antigens). G-CSF is not species-specific and has been shown to have minimal direct in vivo or in vitro effects on the production or activity of hematopoietic cell types other than the neutrophil lineage.
Overdosage
The maximum tolerated dose of NEUPOGEN has not been determined. In NEUPOGEN clinical trials of patients with cancer 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. 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.