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Pegfilgrastim

(Neulasta®)

Neulasta®

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 6 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 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
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  • This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
  • In pediatric and adolescent cancer patients, pegfilgrastim showed no significant difference in preventing febrile neutropenia (FN) compared to filgrastim, with an FN rate of 25.6% (95% confidence interval (CI): 14.9%-36.3%) for pegfilgrastim (odds ratio (OR) = 0.68, 95% CI: 0.20-2.23, P = 0.520).
  • In patients undergoing chemotherapy every two weeks (Q2W), pegfilgrastim demonstrated comparable or improved effectiveness in preventing FN and neutropenia compared to other prophylactic options, including filgrastim, lipegfilgrastim, and pegfilgrastim administered every three weeks (Q3W).
  • For a broader cancer population, pegfilgrastim reduced FN risk relative to filgrastim (OR [95% CI]: 1.63 [1.07, 2.46]), and other agents like mecapegfilgrastim, lipegfilgrastim, and balugrastim also demonstrated effectiveness in FN prevention.
  • In pediatric and adolescent cancer patients receiving pegfilgrastim, observed safety outcomes included a grade 4 FN rate of 38.3%, severe neutropenia (SN) rate of 40.5%, and treatment delays due to FN in 4.8% of cases.
  • Aortitis associated with granulocyte-colony stimulating factor (G-CSF) drugs was noted in 0.3-0.47% of cases, predominantly among females (91.8%) with a mean age of 60.1 years, typically occurring within 10 days post-administration.
  • Specific population findings indicate that in lymphoma patients, pegfilgrastim was identified as a cost-effective option for FN prophylaxis. Additionally, pegfilgrastim demonstrated effective and safe FN and neutropenia prevention in patients on Q2W chemotherapy regimens.