REGIOCIT has been authorized by FDA for emergency use. REGIOCIT is not FDA-approved. REGIOCIT is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of REGIOCIT under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, REGIOCIT: a replacement solution that contains citrate for Regional Citrate Anticoagulation (RCA) of the extracorporeal circuit. REGIOCIT has been authorized for emergency use as a replacement solution in adult patients treated with Continuous Renal Replacement Therapy (CRRT), and for whom RCA is appropriate, during the COVID-19 pandemic. REGIOCIT is intended for use in a critical care setting. REGIOCIT is intended to be used in continuous venovenous hemofiltration (CVVH) and continuous venovenous hemodiafiltration (CVVHDF) modalities. Use of REGIOCIT is limited to healthcare providers and/or institutions that Baxter has qualified to administer REGIOCIT for these emergency uses.
Fact Sheet for Healthcare Providers
REGIOCIT EUA Letter of Authorization