Balugrastim

Granulocyte Colony Stimulating Factor (G CSF) Analog / PEGylated Fusion ProteinRx: PrescriptionCompound: Approved

Also known as: ALBA-GCSF, albumin-G-CSF fusion protein, Neu-Forte

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Balugrastim (Neu-Forte) is a long-acting G-CSF consisting of human albumin genetically fused to G-CSF, providing extended half-life without PEGylation. It is approved in Europe for reducing the duration of neutropenia and incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy.

Mechanism of Action

Binds to and activates the G-CSF receptor on hematopoietic progenitor cells, stimulating proliferation, differentiation, and activation of neutrophil precursors, thereby increasing neutrophil production and reducing duration of chemotherapy-induced neutropenia.

Routes of Administration

Subcutaneous

Goals & Uses

  • Reduction of chemotherapy-induced neutropenia durationHematologic SupportHigh
  • Prevention of febrile neutropeniaInfection PreventionHigh
  • Neutrophil count recoveryHematologic RecoveryHigh

Contraindications

  • Hypersensitivity to balugrastim or G-CSFAllergy/HypersensitivityHigh
  • Severe congenital neutropenia (Kostmann syndrome) with malignant transformationOncologicHigh

Adverse Effects

  • Acute respiratory distress syndrome (ARDS)PulmonaryRare
  • Splenomegaly / splenic ruptureOrgan ToxicityRare
  • Injection site reactionsLocalCommon
  • LeukocytosisHematologicCommon
  • ThrombocytopeniaHematologicUncommonLow platelet count
  • Bone pain / musculoskeletal painMusculoskeletalCommon

Drug Interactions

  • Cytotoxic chemotherapy agentsHigh
  • LithiumLow

Population Constraints

  • Pediatric patientsAgeRelative
  • Patients with sickle cell diseaseHematologic DisorderRelative
  • Pregnant womenReproductiveRelative

Regulatory Status

  • European UnionApprovedApproved: Reduction in duration of severe neutropenia and incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for malignancyApproved by EMA in 2014 under the brand name Neu-Forte.
  • United StatesUnapprovedNot approved by the FDA; no NDA filed as of available data.
  • 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.

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