Filgrastim
Also known as: G-CSF, Granix, Neupogen, Nivestym, r-metHuG-CSF, Zarxio
Summary
Filgrastim is a recombinant human G-CSF used to stimulate neutrophil production in patients with chemotherapy-induced neutropenia, severe chronic neutropenia, and those undergoing bone marrow transplantation or peripheral blood stem cell mobilization. It reduces the incidence of infection manifested by febrile neutropenia.
Mechanism of Action
Binds to and activates the G-CSF receptor on hematopoietic progenitor cells, stimulating proliferation, differentiation, and functional activation of neutrophil precursors, thereby increasing neutrophil production and reducing duration of neutropenia.
Routes of Administration
Goals & Uses
- Reduction of chemotherapy-induced febrile neutropeniaOncology / Supportive CareHigh
- Acceleration of neutrophil recovery post bone marrow transplantTransplantationHigh
- Severe chronic neutropenia managementHematologyHigh
- Peripheral blood stem cell mobilizationHematology / TransplantationHigh
- Acute radiation syndrome (hematopoietic subsyndrome)Radiation EmergencyModerate
Contraindications
- Hypersensitivity to filgrastim or E. coli-derived proteinsAllergy / ImmunologyHigh
- Use in myeloid malignancies (AML/CML) without specific justificationOncologyHigh
Adverse Effects
- Acute respiratory distress syndrome (ARDS)PulmonaryRare
- Splenomegaly / splenic ruptureOrgan ToxicityUncommon
- Injection site reactionsLocalCommon
- LeukocytosisHematologicCommon
- ThrombocytopeniaHematologicUncommonLow platelet count
- Bone pain / musculoskeletal painMusculoskeletalCommon
Drug Interactions
- Chemotherapeutic agentsHigh
- BleomycinModerate
- LithiumLow
Population Constraints
- PregnancyReproductive SafetyRelative
- Renal impairmentOrgan ImpairmentRelative
- Pediatric patientsAgeRelative
- Patients with sickle cell diseaseHematologic DisorderRelative
Regulatory Status
- European UnionApprovedApproved: Reduction of neutropenia duration post chemotherapy, Mobilization of peripheral blood progenitor cells, Severe congenital, cyclic, or idiopathic neutropenia, HIV-associated neutropenia, Post bone marrow transplantationMultiple biosimilars approved by EMA. Reference product Neupogen approved since 1991.
- United StatesApprovedApproved: Chemotherapy-induced neutropenia (non-myeloid malignancies), Bone marrow transplantation, Peripheral blood progenitor cell mobilization, Severe chronic neutropenia, Hematopoietic subsyndrome of acute radiation syndromeOriginally approved 1991; reference product Neupogen (Amgen). Multiple biosimilars approved (Zarxio, Nivestym, Granix, etc.).
- United KingdomApprovedApproved: Chemotherapy-induced neutropenia, Peripheral blood stem cell mobilization, Severe chronic neutropeniaApproved via MHRA; biosimilars also authorized. Regulatory framework follows legacy EMA approval post-Brexit transition.
Approved by FDA in 1991 (Neupogen). Multiple biosimilars approved in the US and EU. Not interchangeable with pegfilgrastim without clinical reassessment.
Evidence & Sources
No sources recorded yet.