Drug updated on 12/11/2024
| 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 nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia
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Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- Eflapegrastim 13.2 mg: Demonstrated high efficacy for febrile neutropenia (the surface under the cumulative ranking (SUCRA) 87%) and severe neutropenia (SUCRA 89.3%), with a significant reduction in duration of severe neutropenia compared to the 1.8 mg dosage (standardized mean difference (SMD) -1.02 [1.63, -0.41; high]).
- Lipegfilgrastim 6 mg: Showed very high efficacy in febrile neutropenia (SUCRA 97.4%) and absolute neutrophil count recovery time (SUCRA 95.2%).
- Dosage Comparison: All dosages (3.6 mg, 4.5 mg, 6 mg, and 13.2 mg) were more effective than 1.8 mg in reducing the duration of severe neutropenia, with SMD ranging from -0.68 to -1.02.
- No significant difference in severe adverse events (SAEs) was observed when increasing the dosage of eflapegrastim from 6 mg to 13.2 mg.
- Higher doses of eflapegrastim (13.2 mg) enhanced efficacy without causing additional SAEs compared to other long-acting granulocyte colony-stimulating factors (LA-G-CSFs), such as lipegfilgrastim 6 mg.
- There is no population types or subgroups information available in the reviewed documents.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Rolvedon (eflapegrastim-xnst) Prescribing Information. | 2023 | Spectrum Pharmaceuticals Inc., Irvine, CA |