Stimufend® (pegfilgrastim-fpgk), a biosimilar to Neulasta® (pegfilgrastim), has been made available by Fresenius Kabi.
Stimufend, a leukocyte growth factor, is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
“The FDA approval of Stimufend was based on the totality of evidence supporting its biosimilarity to Neulasta,” said Brandee Pappalardo, PhD, senior vice president and Chief Medical Officer for Fresenius Kabi USA. “Health care providers and patients can be confident in Stimufend as a treatment option given its proven structural, functional, and clinical similarity, including highly similar safety and tolerability profiles.”
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Stimufend is available in a single-dose, prefilled syringe that delivers 6 mg/0.6 mL solution for subcutaneous injection. The needle cap on the prefilled syringes contains dry natural rubber (derived from latex). Individuals with latex allergies should not administer these products. Health care provider resources and information on patient support programs can be found here.
References
Stimufend® (pegfilgrastim-fpgk) now available in the United States. News release. February 16, 2023. https://www.businesswire.com/news/home/20230215005939/en/Stimufend%C2%AE-pegfilgrastim-fpgk-Now-Available-in-the-United-States.
Stimufend®. Package insert. Fresenius Kabi; 2022. Accessed February 16, 2023. https://www.stimufendhcp.com/sites/default/files/documents/2022-09/stimufend_prescribinginfo_approved_090122.pdf.
This article originally appeared on MPR
