Mecapegfilgrastim

PEGylated Recombinant Human Granulocyte Colony Stimulating Factor (G CSF) AnalogRx: PrescriptionCompound: Approved

Also known as: AGEN-1, Jinhao, mecapegfilgrastim, PEG-rhG-CSF, 津优力

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

Summary

Mecapegfilgrastim (AGEN-1) is a long-acting PEGylated recombinant human G-CSF developed in China for the prevention of chemotherapy-induced neutropenia. It is approved in China and used to reduce the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy.

Mechanism of Action

Binds to G-CSF receptors on hematopoietic progenitor cells, stimulating proliferation, differentiation, and functional activation of neutrophil precursors; PEGylation extends half-life by reducing renal clearance and proteolytic degradation

Routes of Administration

Subcutaneous

Goals & Uses

  • Mobilization of peripheral blood progenitor cellsStem Cell TransplantationLow
  • Reduction of duration of severe neutropeniaHematologic SupportHigh
  • Prevention of chemotherapy-induced febrile neutropeniaHematologic Support / Oncology Supportive CareHigh

Contraindications

  • Myeloid malignancies (AML, CML, MDS)OncologicHigh
  • Use within 14 days before or 24 hours after cytotoxic chemotherapyTiming RestrictionHigh
  • Hypersensitivity to filgrastim, pegfilgrastim, or E. coli-derived proteinsAllergy / ImmunologicHigh

Adverse Effects

  • Acute respiratory distress syndrome (ARDS)PulmonaryRare
  • Splenomegaly / splenic ruptureOrgan ToxicityRare
  • Injection site reactionsLocalCommon
  • LeukocytosisHematologicCommon
  • Allergic/hypersensitivity reactionsImmunologicalUncommon
  • Bone pain / musculoskeletal painMusculoskeletalCommon

Drug Interactions

  • Cytotoxic chemotherapy agentsHigh
  • LithiumLow

Population Constraints

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

Regulatory Status

  • European UnionUnapprovedNot approved by the EMA as of knowledge cutoff
  • United StatesUnapprovedNot approved by the FDA; no IND or BLA filed as of knowledge cutoff
  • United KingdomUnapprovedNot approved by MHRA as of knowledge cutoff; approved and marketed in China by CSPC Pharmaceutical

Approved by China's National Medical Products Administration (NMPA) for reduction of chemotherapy-induced neutropenia. Not approved by US FDA or EMA as of knowledge cutoff.

Evidence & Sources

No sources recorded yet.

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