RELEUKO
RELEUKO (filgrastim-ayow) is a leukocyte growth factor indicated to reduce the incidence of infection and the duration of neutropenia in patients with various malignancies. It is utilized for patients undergoing myelosuppressive chemotherapy, bone marrow transplantation, or treatment for acute myeloid leukemia. The drug also serves to mobilize progenitor cells for collection, manage symptomatic chronic forms of neutropenia, and improve survival in cases of acute radiation exposure.
How RELEUKO Works
RELEUKO acts as a colony-stimulating factor that binds to specific cell surface receptors on hematopoietic cells to stimulate the production of neutrophils. It regulates the proliferation and differentiation of neutrophil progenitors within the bone marrow and enhances the functional activation of mature cells. This process increases phagocytic ability and other cellular functions essential for the immune response while having minimal effect on other cell lineages.
Details
- Status
- Prescription
- First Approved
- 2022-02-25
- Routes
- SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
- Dosage Forms
- SOLUTION
RELEUKO Approval History
What RELEUKO Treats
7 indicationsRELEUKO is approved for 7 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Acute Myeloid Leukemia
- Neutropenia
- Congenital Neutropenia
- Cyclic Neutropenia
- Idiopathic Neutropenia
- Acute Radiation Syndrome
RELEUKO 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.
RELEUKO FDA Label Details
ProIndications & Usage
FDA Label (PDF)RELEUKO 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 maligna...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.