Rusfertide

Is Rusfertide safe?

About four years of open-label follow-up

Injection site reactions are the most common adverse effect. These are redness, itching and swelling where the drug goes in. A majority of patients in REVIVE had them. They were mild and rarely led to stopping. Patients also reported anemia and fatigue. In REVIVE, a few skin cancers (basal and squamous cell) occurred in patients with earlier skin cancer or hydroxyurea exposure. This prompted an FDA clinical hold in 2021, which was lifted after review. The rate did not exceed background in the larger trial. Clots still occur in treated patients. No one has shown whether rusfertide lowers clot risk compared with phlebotomy. Nearly all participants were white and most were over 50. So data in other groups are thin. ¹³

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Reference information only, not medical advice. Drawn from the Rusfertide article, fact-checked against the cited sources. No dosing anywhere on this site.