REGIOCIT Renal Replacement Solution

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.

“We are very excited to offer REGIOCIT to our patients, especially during the coronavirus pandemic. REGIOCIT could be a contributor to helping to improve continuous dialysis, known as continuous renal replacement therapy (CRRT), for COVID-19 patients.  These patients often have high inflammatory syndrome with Cytokine storm leading to continual filter clogging.  REGIOCIT is a dilute citrate commercial solution which provides regional anticoagulation (to CRRT machine) without causing systemic bleeding complications to a patient.  With anticoagulation limited to the circuit specifically, we hope to see improvements in circuit life and overall treatment duration in patients with coagulation abnormalities such as what has been seen in COVID-19 patients. This can possibly extend "continual therapy" time and could impact filter life and staff time. REGIOCIT has undergone rigorous study abroad, and will allow us more options to provide care for our patients requiring continuous dialysis (CRRT).”   

- Ashita Tolwani, MD

Professor in the Division of Nephrology at the University of Alabama at Birmingham School of Medicine, who first developed the solution in 2004

Fact Sheet for Healthcare Providers

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Fact Sheet For Patients

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REGIOCIT EUA Letter of Authorization

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REGIOCIT Specifications

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REGIOCIT EUA Package Insert

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