NEULASTA
Ziextenzo is a leukocyte growth factor indicated to decrease the incidence of infection, manifested as febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. The medication is also approved to increase survival in patients who have been acutely exposed to myelosuppressive doses of radiation, a condition known as Hematopoietic Subsyndrome of Acute Radiation Syndrome. Its therapeutic role is centered on supporting the immune system during treatments or events that suppress bone marrow function. It is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
How NEULASTA Works
This medication acts as a colony-stimulating factor that targets hematopoietic cells within the body. By binding to specific cell surface receptors, the drug stimulates the proliferation, differentiation, and commitment of these cells. This process leads to the functional activation of end cells, which helps restore and maintain essential white blood cell populations. This mechanism is essential for mitigating the effects of myelosuppression caused by chemotherapy or radiation exposure.
Details
- Status
- Prescription
- First Approved
- 2002-01-31
- Routes
- N/A
- Dosage Forms
- SYRINGE
NEULASTA Approval History
What NEULASTA Treats
2 indicationsNEULASTA is approved for 2 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Acute Radiation Syndrome
NEULASTA is a lower-cost alternative to Neulasta 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.
NEULASTA FDA Label Details
ProIndications & Usage
FDA Label (PDF)ZIEXTENZO is a leukocyte growth factor 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). Limitations of Use ZIEXTENZO is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients wit...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.