These highlights do not include all the information needed to use NIVESTYM safely and effectively. See full prescribing information for NIVESTYM. NIVESTYM™ (filgrastim-aafi) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2018 NIVESTYM (filgrastim-aafi) is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.Biosimilarity of NIVESTYM has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to NEUPOGEN (filgrastim).

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These highlights do not include all the information needed to use NIVESTYM safely and effectively. See full prescribing information for NIVESTYM. NIVESTYM™ (filgrastim-aafi) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2018 NIVESTYM (filgrastim-aafi) is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.Biosimilarity of NIVESTYM has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to NEUPOGEN (filgrastim).

Medication label

Why this: Advisory · dailymed-prescription

NIVESTYM is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever [see Clinical Studies (14.1)]. NIVESTYM is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) [see Clinical Studies (14.2)]. NIVESTYM is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation [see Clinical Studies (14.3)]. NIVESTYM is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis [see Clinical Studies (14.4)]. NIVESTYM is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia [see Clinical Studies (14.5)].

generic_name: filgrastim-aafi
product_names: filgrastim-aafi
ndc: 0069-0291, 0069-0292, 0069-0293, 0069-0294, 0069-0293-01, 0069-0293-10, 0069-0294-01, 0069-0294-10, 0069-0291-01, 0069-0291-10, 0069-0292-01, 0069-0292-10
group: drugs
license: us-gov-pd
attribution: Courtesy of the National Library of Medicine
reviewed: 2026-09-18
language: en