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Neupogen (Filgrastim-Aafi)
Filgrastim-aafi binds G-CSF receptors on hematopoietic cells, stimulating neutrophil proliferation, differentiation, and functional activation.
Filgrastim-aafi is a recombinant G-CSF analog indicated for reducing infection risk in cancer patients receiving myelosuppressive chemotherapy, accelerating neutrophil recovery in AML, supporting bone marrow transplantation, mobilizing progenitor cells, and managing severe chronic neutropenia. The drug exhibits nonlinear pharmacokinetics with a 3.5-hour half-life and 60-70% subcutaneous bioavailability, cleared via receptor-mediated and renal mechanisms. Primary risk is serious allergic reactions in patients with prior hypersensitivity to G-CSF products. Filgrastim-aafi provides established clinical benefit across multiple hematologic and oncologic indications with well-characterized pharmacokinetic properties.
At a glance
| Generic name | Filgrastim-Aafi |
|---|---|
| Sponsor | Amgen |
| Drug class | Colony-stimulating factor (CSF); leukocyte growth factor |
| Target | G-CSF receptor (granulocyte colony-stimulating factor receptor) |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1991 |
| Annual revenue | 1434 |
Mechanism of action
Filgrastim-aafi is a glycoprotein that acts on hematopoietic cells by binding to specific cell surface G-CSF receptors. This binding stimulates proliferation, differentiation commitment, and end-cell functional activation of neutrophil progenitors. Endogenous G-CSF is produced by monocytes, fibroblasts, and endothelial cells and regulates neutrophil production within the bone marrow. G-CSF regulates neutrophil progenitor proliferation and differentiation while enhancing selected end-cell functions including enhanced phagocytic ability, priming of cellular metabolism associated with respiratory burst, antibody-dependent killing, and increased expression of cell surface antigens. The drug exhibits lineage-specific effects with minimal direct in vivo or in vitro effects on hematopoietic cell types other than the neutrophil lineage.
Approved indications
- Chemotherapy-induced neutropenia
- Chronic idiopathic neutropenia
- Congenital neutropenia
- Cyclical neutropenia
- Enhancement of an antitumor effect of dinutuximab for neuroblastoma
- Refractory acute myeloid leukemia
- Relapsed acute myeloid leukemia
Common side effects
- Neutrophil count decreased
- Platelet count decreased
- Febrile neutropenia
- Hypokalemia
- White blood cell decreased
- Anemia
- Infections and infestations - Other, specify
- Mucositis oral
- Alanine aminotransferase increased
- Anorexia
- Hyperglycemia
- Aspartate aminotransferase increased
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| SEC EDGAR | Revenue + earnings |
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