Eflapegrastim
Also known as: Eflapegrastim, eflapegrastim-xnst, HM10460A, RGL‑001, Rolvedon, SPI-2012
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Summary
Eflapegrastim is a long‑acting recombinant human G‑CSF fused to an IgG4 Fc fragment and PEGylated to extend its half‑life. It is administered subcutaneously to reduce the duration of chemotherapy‑induced neutropenia.
Mechanism of Action
Agonist of the G‑CSF receptor; stimulates proliferation, differentiation and activation of neutrophil precursors, increasing peripheral neutrophil counts.
Routes of Administration
Goals & Uses
- Shortening duration of severe neutropenia (DSN)OncologyModerate
- Reduction of febrile neutropenia riskOncology Supportive CareHigh
- Prevention of chemotherapy-induced severe neutropeniaOncology Supportive CareHigh
- Shortened duration of severe neutropeniaHematologyHigh
- Reduction of chemotherapy‑induced neutropeniaOncologyModerate
Contraindications
- Hypersensitivity to eflapegrastim or any excipientAllergyHigh
- Patients with known myeloid malignancies (e.g., CML, AML) in blast phaseOncologyModerate
- Hypersensitivity to eflapegrastim or any componentAllergy/ImmunologyHigh
- Administration between 14 days before and 24 hours after cytotoxic chemotherapyTiming RestrictionHigh
Adverse Effects
- Acute respiratory distress syndrome (ARDS)PulmonaryRare
- Splenomegaly / splenic ruptureOrgan ToxicityRare
- Bone painMusculoskeletalCommon
- Injection site reactionsLocalCommon
- LeukocytosisHematologicCommon
- Splenic ruptureGastrointestinal/HematologicRare
- Injection‑site reactionsLocalCommon
- AortitisCardiovascularRare
- Bone pain / musculoskeletal painMusculoskeletalCommon
Drug Interactions
- Cytotoxic chemotherapy agentsHigh
- LithiumModerate
- Concurrent myelosuppressive chemotherapyModerate
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patientsAgeRelative
- LactationReproductiveRelative
- Pregnant or breastfeeding womenReproductiveRelative
- Sickle cell diseaseHematologicRelative
- Myeloid malignanciesOncologicAbsolute
- Pediatric patients <2 yearsAgeRelative
Regulatory Status
- European UnionUnknownNo marketing authorization granted yet.
- United StatesInvestigationalPhase III data submitted; FDA decision pending as of 2024.
- United KingdomUnknownNot approved by MHRA as of knowledge cutoff
FDA approved September 9, 2022 under brand name Rolvedon. Developed by Spectrum Pharmaceuticals. Not yet approved in EU or UK as of knowledge cutoff.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Eflapegrastim?
Eflapegrastim is a long‑acting recombinant human G‑CSF fused to an IgG4 Fc fragment and PEGylated to extend its half‑life. It is administered subcutaneously to reduce the duration of chemotherapy‑induced neutropenia.
What is Eflapegrastim used for?
Eflapegrastim is educationally associated with: Shortening duration of severe neutropenia (DSN), Reduction of febrile neutropenia risk, Prevention of chemotherapy-induced severe neutropenia, Shortened duration of severe neutropenia, Reduction of chemotherapy‑induced neutropenia. Educational only — not medical advice.
How is Eflapegrastim administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Eflapegrastim?
Reported adverse effects include: Acute respiratory distress syndrome (ARDS), Splenomegaly / splenic rupture, Bone pain, Injection site reactions, Leukocytosis, Splenic rupture, Injection‑site reactions, Aortitis, Bone pain / musculoskeletal pain. This list is not exhaustive — consult a qualified clinician.
Who should avoid Eflapegrastim?
Recorded contraindications: Hypersensitivity to eflapegrastim or any excipient, Patients with known myeloid malignancies (e.g., CML, AML) in blast phase, Hypersensitivity to eflapegrastim or any component, Administration between 14 days before and 24 hours after cytotoxic chemotherapy. Consult a qualified clinician before use.