NIVESTYM
Nivestym (filgrastim-aafi) is a leukocyte growth factor used to manage neutropenia and reduce the risk of infection in patients with various cancers and blood disorders. It is primarily indicated for patients receiving myelosuppressive or myeloablative chemotherapy, including those undergoing bone marrow transplantation or treatment for acute myeloid leukemia. The drug also serves to mobilize progenitor cells for collection and to treat symptomatic patients with chronic forms of neutropenia, such as congenital, cyclic, or idiopathic types.
How NIVESTYM Works
Nivestym acts as a colony-stimulating factor by binding to specific receptors on the surface of hematopoietic cells. This binding stimulates the proliferation and differentiation of neutrophil progenitors within the bone marrow, regulating the production of mature neutrophils. Additionally, the drug enhances the functional activation of these cells, increasing their phagocytic ability and antibody-dependent killing to better combat infections.
Details
- Status
- Prescription
- First Approved
- 2018-07-20
- Routes
- INJECTION, SINGLE-DOSE
- Dosage Forms
- INJECTABLE, VIAL
NIVESTYM Approval History
What NIVESTYM Treats
6 indicationsNIVESTYM is approved for 6 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Acute Myeloid Leukemia
- Neutropenia
- Congenital Neutropenia
- Cyclic Neutropenia
- Idiopathic Neutropenia
NIVESTYM is a lower-cost alternative to Neupogen with no clinically meaningful differences. Requires prescriber approval to substitute.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NIVESTYM FDA Label Details
ProIndications & Usage
FDA Label (PDF)NIVESTYM is a leukocyte growth factor 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. • Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML). • Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid ma...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.