Drug updated on 5/17/2024
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
- Pegfilgrastim (Neulasta) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. It is also used to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
- Three studies provided a comprehensive analysis of the efficacy and safety profile of pegfilgrastim compared with similar drugs.
- The timing of administration is crucial in maximizing its effectiveness; next-day administration after chemotherapy was found to be more effective than same-day administration at reducing the risk of febrile neutropenia without compromising safety, particularly among breast cancer and lymphoma patients.
- Compared to 11 Granulocyte Colony-Stimulating Factors (G-CSFs), pegfilgrastim had lower risks associated with febrile neutropenia and bone pain incidences than filgrastim, short-acting G-CSF biosimilars, and lenograstim. However, mecapegfilgrastim, lipegfilgrastim, and balugrastim showed better efficacy profiles.
- For biweekly regimens involving high or intermediate-risk chemotherapy treatments across various non-myeloid malignancies, including breast cancer or lymphoma subgroups, it demonstrated comparable rates or decreased instances of febrile neutropenia/neutropenia versus filgrastim/no G-CSF/lipegfilgrastim/pegfilgrastim triweekly regimens, indicating its broad-spectrum applicability while maintaining safety levels.
- Despite having favorable outcomes when administered correctly after chemotherapy sessions for prophylaxis against infections such as Febrile Neutropenia during treatment cycles involving myelosuppressive anti-cancer drugs, newer alternatives such as mecapegfilgrastim, lipegfilgrastim, and balugrastim may offer better efficacy and tolerability depending on the patient subgroups/malignancy types.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Neulasta (pegfilgrastim) Prescribing Information. | 2021 | Amgen Inc., Thousand Oaks, California |