Eflapegrastim

(Rolvedon®)

Eflapegrastim

Drug updated on 9/4/2024

Dosage FormInjection (subcutaneous; 13.2 mg/0.6 mL)
Drug ClassLeukocyte growth factors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

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Summary
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  • Rolvedon (eflapegrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
  • Incidence and Duration of Severe Neutropenia (SN): Eflapegrastim 13.2 mg significantly reduces the incidence of severe neutropenia with a SUCRA of 89.3% and effectively decreases the duration of severe neutropenia (SMD -1.02 [1.63, -0.41; high]).
  • Incidence of Febrile Neutropenia (FN): Eflapegrastim 13.2 mg and lipegfilgrastim 6 mg reduce the incidence of febrile neutropenia, with SUCRA values of 87% and 97.4%, respectively.
  • Absolute Neutrophil Count Recovery Time (ANCrt): Lipegfilgrastim 6 mg improves ANC recovery time with a SUCRA of 95.2%.
  • Eflapegrastim 13.2 mg and lipegfilgrastim 6 mg demonstrated comparable safety profiles, with no significant difference in the incidence of severe adverse events (SAEs) when increasing the dosage of eflapegrastim from 6 mg to 13.2 mg.
  • There were no specific significant safety concerns or adverse effects reported for eflapegrastim 13.2 mg or other dosages in the population of breast cancer patients undergoing chemotherapy.
  • The studied population consists of patients with breast cancer undergoing chemotherapy, with no additional subgroups specified; eflapegrastim 13.2 mg and lipegfilgrastim 6 mg demonstrated high efficacy and few safety concerns for this population, with higher doses of LA-G-CSF enhancing efficacy without additional safety risks.

Product Monograph / Prescribing Information

Document TitleYearSource
Rolvedon (eflapegrastim-xnst) prescribing information. 2022Spectrum Pharmaceuticals Inc., Irvine, CA

Systematic Reviews / Meta-Analyses