ARMLUPEG (pegfilgrastim-unne)
Armlupeg is a leukocyte growth factor indicated for use in adult and pediatric patients, including newborns. It is primarily used to reduce the risk of infection, specifically febrile neutropenia, in patients with non-myeloid malignancies undergoing myelosuppressive chemotherapy. Additionally, the drug is approved to improve survival rates in individuals who have experienced acute exposure to myelosuppressive doses of radiation. It is not intended for the mobilization of peripheral blood progenitor cells during hematopoietic stem cell transplantation.
How ARMLUPEG Works
Armlupeg functions as a colony-stimulating factor that targets hematopoietic cells. The drug works by binding to specific receptors located on the surface of these cells. This binding action triggers the proliferation, differentiation, and commitment of the cells, ultimately leading to their functional activation. By stimulating these biological processes, the medication helps manage the effects of myelosuppression.
Details
- Status
- Prescription
- First Approved
- 2025-11-28
- Routes
- SOLUTION
- Dosage Forms
- INJECTION
ARMLUPEG Approval History
What ARMLUPEG Treats
2 indicationsARMLUPEG is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Febrile Neutropenia
- Acute Radiation Syndrome
ARMLUPEG is a lower-cost alternative to Neulasta with no clinically meaningful differences. Requires prescriber approval to substitute.
ARMLUPEG Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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.
ARMLUPEG FDA Label Details
Indications & Usage
ARMLUPEG is indicated for the treatment of Febrile Neutropenia; Acute Radiation Syndrome.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.