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Neulasta (Pegfilgrastim-Apgf)
Colony-stimulating factor binding hematopoietic cell surface receptors to stimulate proliferation and differentiation.
Pegfilgrastim-Apgf is a pegylated G-CSF indicated to decrease febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy. The drug demonstrates nonlinear pharmacokinetics with half-lives ranging 15-80 hours and clearance dependent on neutrophil count and body weight. Contraindications include serious allergic reactions to pegfilgrastim or filgrastim products. The drug is not indicated for peripheral blood progenitor cell mobilization for hematopoietic stem cell transplantation.
At a glance
| Generic name | Pegfilgrastim-Apgf |
|---|---|
| Sponsor | Amgen |
| Drug class | Colony-stimulating factor |
| Target | G-CSF receptor on hematopoietic cells |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2002 |
| Annual revenue | 1200 |
Mechanism of action
Pegfilgrastim-Apgf is a pegylated granulocyte colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors. This binding stimulates proliferation, differentiation, commitment, and end cell functional activation of neutrophil precursor cells. The pegylation extends the half-life compared to filgrastim, allowing for less frequent dosing in patients receiving myelosuppressive chemotherapy.
Approved indications
- Allogeneic peripheral blood stem cell transplant
- Chemotherapy-induced neutropenia
Common side effects
- Platelet count decreased
- Anemia
- Neutrophil count decreased
- White blood cell decreased
- Fatigue
- Hypokalemia
- Hyperglycemia
- Nausea
- Alanine aminotransferase increased
- Diarrhea
- Hypocalcemia
- Aspartate aminotransferase increased
Key clinical trials
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer (PHASE2,PHASE3)
- Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma (PHASE2)
- Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia (PHASE2)
- A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT (PHASE2)
- Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (PHASE2)
- Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia (PHASE2)
- Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma (PHASE1)
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 |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Neulasta CI brief — competitive landscape report
- Neulasta updates RSS · CI watch RSS
- Amgen portfolio CI