Rusfertide
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Overview
Rusfertide (brand name MIMRYLO) is a synthetic hepcidin-mimetic peptide developed by Protagonist Therapeutics and Takeda. It is FDA-approved for the treatment of erythrocytosis in adults with polycythemia vera (PV), a myeloproliferative blood cancer marked by overproduction of red blood cells. Rusfertide works by blocking ferroportin, the protein that exports iron from cells, which limits the iron supply available for red blood cell production. It is administered as an addition to a patient's existing standard-of-care treatment for PV, such as therapeutic phlebotomy or cytoreductive therapy, rather than as a stand-alone replacement for either.
Reported benefits
In the Phase 3 VERIFY trial, adding rusfertide to standard-of-care therapy allowed 76.9% of participants to achieve hematocrit control without phlebotomy during weeks 20-32, compared with 32.9% on placebo plus standard of care. Reported benefits are specific to polycythemia vera erythrocytosis management and have not been studied for other conditions.
Protocols & dosing
Typical dosage: 19-108 mg (once weekly, subcutaneous).
Detailed dosing protocols have not yet been catalogued.
FDA & legal status
Rusfertide is approved by the U.S. Food and Drug Administration for one or more labeled indications. Approval covers only the labeled indication, population and dosing. Refer to the prescribing information for full safety and dosing details.
| Country | Status |
|---|---|
| United States | FDA approved |
| United Kingdom | Prescription-only / not licensed |
| Canada | Prescription-only / Schedule F if licensed |
| Australia | TGA-scheduled |
Vendor information
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Side effects & safety
Reported side effects: Injection-site reactions (56%) and anemia (16%) were the most common adverse events in clinical trials; labeled warnings include thrombocytosis and embryo-fetal toxicity.
References
No external sources have been catalogued for this article yet.
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