Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 13.2 mg/0.6 mL) |
Drug Class | Leukocyte 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
- 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 Title | Year | Source |
---|---|---|
Rolvedon (eflapegrastim-xnst) prescribing information. | 2022 | Spectrum Pharmaceuticals Inc., Irvine, CA |