Balugrastim
Also known as: ALBA-GCSF, albumin-G-CSF fusion protein, Balugrastim, Filgrastim biosimilar, Neu-Forte
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Summary
Balugrastim is a recombinant human G‑CSF used to reduce the duration of neutropenia in patients receiving myelosuppressive chemotherapy.
Mechanism of Action
Binds G‑CSF receptor on myeloid progenitors, stimulating proliferation and differentiation of neutrophils
Routes of Administration
Goals & Uses
- Prevention of chemotherapy‑induced neutropeniaOncology Supportive CareHigh
- Reduction of chemotherapy-induced neutropenia durationHematologic SupportHigh
- Prevention of febrile neutropeniaInfection PreventionHigh
- Neutrophil count recoveryHematologic RecoveryHigh
Contraindications
- Hypersensitivity to balugrastim or G-CSFAllergy/HypersensitivityHigh
- Active myeloid malignancyCancerModerate
- Known hypersensitivity to filgrastim or E. coli‑derived proteinsAllergyHigh
- Severe congenital neutropenia (Kostmann syndrome) with malignant transformationOncologicHigh
Adverse Effects
- Acute respiratory distress syndrome (ARDS)PulmonaryRare
- Splenomegaly / splenic ruptureOrgan ToxicityRare
- Bone painMusculoskeletalCommon
- Injection site reactionsLocalCommon
- LeukocytosisHematologicUncommon
- ThrombocytopeniaHematologicUncommonLow platelet count
- Bone pain / musculoskeletal painMusculoskeletalCommon
Drug Interactions
- Cytotoxic chemotherapy agentsHigh
- Chemotherapy agents (e.g., cyclophosphamide)Moderate
- LithiumLow
Population Constraints
- Pediatric patientsAgeRelative
- Patients with sickle cell diseaseHematologic DisorderRelative
- Pregnant womenReproductiveRelative
Regulatory Status
- European UnionUnapprovedNot authorized in EU
- RUApprovedApproved: Chemotherapy‑induced neutropeniaApproved by Russian Ministry of Health
- United StatesUnapprovedNot FDA‑approved; filgrastim available as Neupogen
- United KingdomApprovedApproved: Reduction of duration of neutropenia and febrile neutropenia in adults receiving cytotoxic chemotherapyWas approved under EMA authorization prior to Brexit; post-Brexit status subject to MHRA review.
Approved by the EMA in 2014 for chemotherapy-induced neutropenia. Not approved by the FDA in the US. Developed by Teva Pharmaceuticals.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Balugrastim?
Balugrastim is a recombinant human G‑CSF used to reduce the duration of neutropenia in patients receiving myelosuppressive chemotherapy.
What is Balugrastim used for?
Balugrastim is educationally associated with: Prevention of chemotherapy‑induced neutropenia, Reduction of chemotherapy-induced neutropenia duration, Prevention of febrile neutropenia, Neutrophil count recovery. Educational only — not medical advice.
How is Balugrastim administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Balugrastim?
Reported adverse effects include: Acute respiratory distress syndrome (ARDS), Splenomegaly / splenic rupture, Bone pain, Injection site reactions, Leukocytosis, Thrombocytopenia, Bone pain / musculoskeletal pain. This list is not exhaustive — consult a qualified clinician.
Who should avoid Balugrastim?
Recorded contraindications: Hypersensitivity to balugrastim or G-CSF, Active myeloid malignancy, Known hypersensitivity to filgrastim or E. coli‑derived proteins, Severe congenital neutropenia (Kostmann syndrome) with malignant transformation. Consult a qualified clinician before use.