ZARXIO
Zarxio is a leukocyte growth factor used to reduce the risk of infection and clinical complications in patients with various forms of neutropenia. It is indicated for patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy or undergoing bone marrow transplantation, as well as those with acute myeloid leukemia. The drug also serves to mobilize hematopoietic progenitor cells for collection and to improve survival in patients experiencing acute exposure to myelosuppressive doses of radiation.
How ZARXIO Works
Zarxio functions as a colony-stimulating factor that binds to specific receptors on hematopoietic cells to stimulate the production and activation of neutrophils. By regulating bone marrow activity, the drug promotes the proliferation and differentiation of neutrophil progenitors into functional white blood cells. This process enhances the immune system's end-cell functions, including phagocytic ability and antibody-dependent killing, while having minimal effect on other cell lineages.
Details
- Status
- Prescription
- First Approved
- 2015-03-06
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ZARXIO Approval History
What ZARXIO Treats
7 indicationsZARXIO is approved for 7 conditions since its original approval in 2015. 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
ZARXIO is a lower-cost alternative to Neupogen with no clinically meaningful differences. Requires prescriber approval to substitute.
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Active Pipeline
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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.
ZARXIO FDA Label Details
ProIndications & Usage
FDA Label (PDF)ZARXIO 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 malign...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.