ATC codes: L03AA13
Acquired neutropaenia ICD11 code: 4B00.01
Medicine type
Biological agent
List type
Complementary (EML)
Additional notes
Including quality-assured biosimilars.
Parenteral > General injections > SC: 6 mg per 0.6 mL in pre-filled syringe
EML status history
First added in 2023 (TRS 1049)
Also recommended for children
Therapeutic alternatives
The recommendation is for this specific medicine
Patent information
Main patents have expired but secondary patents might remain active in some jurisdictions. For more information on specific patents and license status for developing countries visit www.MedsPal.org
Summary of evidence and Expert Committee recommendations
The Expert Committee recommended the inclusion of pegfilgrastim (including quality-assured biosimilars) on the complementary list of the EML and EMLc for primary prophylaxis in patients at high risk for developing febrile neutropenia associated with myelotoxic chemotherapy, and for secondary prophylaxis in patients who have experienced neutropenia following prior myelotoxic chemotherapy. The Committee noted that a single dose of pegfilgrastim (once every two weeks) is an efficacious and safe alternative to daily injections of filgrastim. The Committee considered that pegfilgrastim may offer advantages over filgrastim in settings where refrigerated storage outside of secondary treatment centers is limited. In these settings, patients being treated with filgrastim face longer hospital stays or daily clinic visits and this has been associated with lower adherence to treatment and increased risk of life-threatening infections. The Committee noted that filgrastim remains a relevant treatment option for patients in whom a treatment duration of less than 2 weeks is indicated.