Efbemalenograstim alfa

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

Also known as: efbemalenograstim alfa, GW003, long-acting G-CSF, ROLVEDON

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

Summary

Efbemalenograstim alfa (ROLVEDON) is a long-acting G-CSF analog consisting of recombinant human G-CSF conjugated to a human serum albumin-binding domain via a PEG linker. It is approved to decrease the incidence of infection as manifested by febrile neutropenia in adults with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. It is administered as a single subcutaneous injection per chemotherapy cycle.

Mechanism of Action

Binds to the G-CSF receptor on hematopoietic progenitor cells, stimulating proliferation, differentiation, and activation of neutrophil precursors, thereby increasing circulating neutrophil counts. The PEGylated albumin-binding domain prolongs half-life compared to filgrastim.

Routes of Administration

Subcutaneous

Goals & Uses

  • Prevention of febrile neutropeniaInfection PreventionHigh
  • Maintenance of chemotherapy dose intensityOncologyModerate
  • Reduction in chemotherapy-induced neutropenia durationHematologyHigh

Contraindications

  • Hypersensitivity to efbemalenograstim alfa or any excipientAllergy/ImmunologyHigh
  • Use in patients with myeloid malignanciesOncologyHigh

Adverse Effects

  • Acute respiratory distress syndrome (ARDS)PulmonaryRare
  • Injection site reactionsLocalCommon
  • LeukocytosisHematologicCommon
  • Splenic ruptureGastrointestinal/HematologicRare
  • Bone pain / musculoskeletal painMusculoskeletalCommon
  • GlomerulonephritisRenalRare

Drug Interactions

  • Topoisomerase II inhibitors / other chemotherapy agentsHigh
  • LithiumLow

Population Constraints

  • PregnancyReproductive SafetyRelative
  • Pediatric patientsAgeRelative
  • LactationReproductiveRelative
  • Sickle cell diseaseHematologicRelative

Regulatory Status

  • European UnionUnknownNo EMA approval identified as of knowledge cutoff; not listed as an authorized medicinal product in the EU.
  • United StatesApprovedApproved: To decrease the incidence of infection, as manifested by febrile neutropenia, in adults with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropeniaFDA approved September 9, 2022 under the brand name ROLVEDON. Marketed by Spectrum Pharmaceuticals.
  • United KingdomUnknownNo MHRA authorization identified as of knowledge cutoff.

Approved by the FDA in September 2022 for prevention of chemotherapy-induced febrile neutropenia. Not yet approved by EMA or MHRA as a distinct product. Biosimilar considerations do not apply as it is a novel molecular entity.

Evidence & Sources

No sources recorded yet.

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