Drug updated on 9/4/2024
Dosage Form | Injection (subcutaneous; 6 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 patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
- Indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
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Summary
- Neulasta (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Pegfilgrastim, when administered on the same day of chemotherapy completion, resulted in significantly higher febrile neutropenia (FN) rates compared to administration at least one day after chemotherapy (OR=2.56 in the first cycle, OR=1.54 across all cycles).
- Compared to pegfilgrastim, newer G-CSFs such as mecapegfilgrastim, lipegfilgrastim, and balugrastim were more effective in reducing FN rates. Filgrastim had a higher risk for FN (OR=1.63), and S-G-CSF biosimilar, empegfilgrastim, and L-G-CSF biosimilar were most effective in reducing severe neutropenia (SN).
- Prophylactic pegfilgrastim in patients receiving biweekly (Q2W) regimens resulted in decreased or comparable FN rates and neutropenia compared to patients receiving filgrastim, no G-CSF, lipefilgrastim, or pegfilgrastim in Q3W regimens.
- Higher incidence of bone pain was observed in patients with gynecological malignancies using same-day pegfilgrastim (OR=1.30), with short-acting G-CSF biosimilar (OR=6.45) and lenograstim (OR=5.12) showing even higher risks compared to pegfilgrastim.
- Same-day pegfilgrastim administration was associated with a lower incidence of chemotherapy delay (OR=0.71).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Neulasta (pegfilgrastim) Prescribing Information. | 2021 | Amgen Inc., Thousand Oaks, California |