Balugrastim
Also known as: ALBA-GCSF, albumin-G-CSF fusion protein, Balugrastim, Filgrastim biosimilar, Neu-Forte
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Summary
Balugrastim is a long‑acting, albumin‑fused granulocyte colony‑stimulating factor (G‑CSF) given by subcutaneous injection to support neutrophil recovery in patients receiving myelosuppressive chemotherapy. Clinical trials, principally in breast‑cancer regimens, have shown it to be non‑inferior to pegfilgrastim in reducing the duration of severe neutropenia and febrile neutropenia, with a comparable safety profile.
Mechanism of Action
Balugrastim combines recombinant human serum albumin with G‑CSF, enabling binding to the G‑CSF receptor on hematopoietic progenitor cells. Activation of this receptor stimulates proliferation, differentiation, and activation of neutrophil precursors, accelerating recovery of absolute neutrophil counts after chemotherapy. Albumin fusion increases molecular size and plasma stability, extending the elimination half‑life to enable a single dose per chemotherapy cycle.
What the Research Shows
Phase II dose‑finding work identified 40–50 mg doses that matched pegfilgrastim’s efficacy, with similar adverse‑event rates. Two Phase III, double‑blind trials in breast‑cancer patients receiving doxorubicin/docetaxel demonstrated that balugrastim (40 mg or 50 mg) produced a mean duration of severe neutropenia (DSN) of 1.0–1.3 days in cycle 1, statistically non‑inferior to pegfilgrastim’s 1.2 days. Systematic reviews of long‑acting G‑CSFs reported balugrastim’s efficacy and safety as comparable to pegfilgrastim, and a Bayesian network meta‑analysis placed balugrastim among the top agents for reducing febrile neutropenia, severe neutropenia, and bone pain. Across studies, immunogenicity was low and transient.
Reported Benefits
Balugrastim provides once‑per‑cycle neutrophil support, simplifying dosing compared with daily short‑acting G‑CSFs. Clinical data show it shortens the duration of severe neutropenia similarly to pegfilgrastim, potentially reducing infection risk and chemotherapy delays. The albumin fusion yields a prolonged half‑life, allowing a single subcutaneous injection after chemotherapy, and the safety profile is comparable, with bone pain as the most common mild adverse event.
Limitations of the Evidence
Evidence is largely confined to breast‑cancer patients receiving doxorubicin‑docetaxel; data for other tumour types or chemotherapy regimens are limited. Most comparative information involves pegfilgrastim, and long‑term safety beyond trial periods has not been fully characterised. The number of published trials is modest, and real‑world effectiveness remains to be confirmed in broader patient populations.
Safety Considerations
Balugrastim’s adverse‑event spectrum mirrors that of other long‑acting G‑CSFs, with mild to moderate bone pain reported most frequently. Serious adverse events were rare and similar in frequency to pegfilgrastim. Immunogenicity was low, transient, and non‑neutralising. No unexpected safety signals emerged in the phase II and III studies, but clinicians should monitor for typical G‑CSF‑related effects such as splenic enlargement or leukocytosis.
How It Is Administered
Balugrastim is administered as a single subcutaneous injection once per chemotherapy cycle, typically at a fixed dose of 40 mg or 50 mg given about 24 hours after chemotherapy. The formulation is a recombinant albumin‑G‑CSF fusion protein supplied for subcutaneous use.
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
- Journal ArticleModerateGladkov O, et al.2016-01-01T00:00:00.000000Z
- Journal ArticleHighPfeil AM, et al.2015-01-01T00:00:00.000000Z
- Journal ArticleHighWang Y, et al.2019-01-01T00:00:00.000000Z
- Journal ArticleModerateGhidini M, et al.2016-01-01T00:00:00.000000Z
- Journal ArticleModerateVolovat C, et al.2014-01-01T00:00:00.000000Z
- Journal ArticleModerateGladkov O, et al.2015-01-01T00:00:00.000000Z
Frequently Asked Questions
What type of medication is balugrastim?
Balugrastim is a recombinant, long‑acting granulocyte colony‑stimulating factor that combines human serum albumin with G‑CSF to stimulate neutrophil production after chemotherapy.
How does balugrastim differ from pegfilgrastim?
Both are long‑acting G‑CSFs given once per cycle, but balugrastim uses an albumin‑fusion to extend its half‑life, whereas pegfilgrastim is pegylated. Clinical trials show comparable efficacy and safety.
What are the common side effects?
The most frequently reported side effect is mild to moderate bone pain. Overall adverse‑event rates, including serious events, were similar to those seen with pegfilgrastim.
Who is most likely to benefit from balugrastim?
Patients receiving myelosuppressive chemotherapy with a ≥20 % risk of febrile neutropenia—particularly those with breast cancer treated with doxorubicin‑docetaxel—have been studied and shown benefit.
Is balugrastim approved for use?
Balugrastim is an approved prescription medicine and is indicated for neutrophil support in patients undergoing chemotherapy, as reflected by its regulatory status.
What is Balugrastim?
Balugrastim is a long‑acting, albumin‑fused granulocyte colony‑stimulating factor (G‑CSF) given by subcutaneous injection to support neutrophil recovery in patients receiving myelosuppressive chemotherapy. Clinical trials, principally in breast‑cancer regimens, have shown it to be non‑inferior to pegfilgrastim in reducing the duration of severe neutropenia and febrile neutropenia, with a comparable safety profile.
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.