Stimufend FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 17, 2024.
FDA Approved: Yes (First approved September 1, 2022)
Brand name: Stimufend
Generic name: pegfilgrastim-fpgk
Dosage form: Injection
Company: Fresenius Kabi USA, LLC
Treatment for: Neutropenia Associated with Chemotherapy, Neutropenia Associated with Radiation
Stimufend (pegfilgrastim-fpgk) is a leukocyte growth factor biosimilar to Neulasta (pegfilgrastim) used to reduce the duration of febrile neutropenia in patients treated with chemotherapy and to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
- Stimufend 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.
- increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). - Stimufend was approved as a biosimilar based on data demonstrating that it is highly similar to the FDA-approved biological reference product containing pegfilgrastim, and that there are no clinically meaningful differences between the biosimilar product and the reference product.
- Stimufend is administered via subcutaneous injection once per chemotherapy cycle for patients receiving chemotherapy, and as two doses one week apart for patients acutely exposed to myelosuppressive doses of radiation.
- The injection is supplied in a single-dose pre-filled syringe 6 mg/0.6 mL.
- Warnings and precautions associated with Stimufend include splenic rupture; acute respiratory distress syndrome; serious allergic reactions; sickle cell crises; glomerulonephritis; thrombocytopenia; and an increased risk of myelodysplastic syndrome and/or acute myeloid leukemia in patients with breast and lung cancer who receive Stimufend in conjunction with chemotherapy and/or radiation therapy.
- Common adverse reactions include bone pain and pain in extremities.
- Stimufend is the sixth FDA-approved pegfilgrastim biosimilar, after the approvals of Fylnetra (pegfilgrastim-pbbk), Nyvepria (pegfilgrastim-apgf), Ziextenzo (pegfilgrastim-bmez ), Udenyca (pegfilgrastim-cbqv) and Fulphila (pegfilgrastim-jmdb).
Development timeline for Stimufend
| Date | Article |
|---|---|
| Sep 6, 2022 | Approval FDA Approves Stimufend (pegfilgrastim-fpgk), a Biosimilar to Neulasta |
Further information
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