Drug intelligence / Profile preview

Regiocit

Development stage
Phase 3
Lead developer
Takeda
Modality
Small Molecules
Administration
Extracorporeal
01

Overview

Regiocit is a **sterile, replacement solution** composed of **sodium chloride (5.03 g/L)** and **sodium citrate (5.29 g/L)**, designed for use as a replacement solution for **regional citrate anticoagulation (RCA)** of the extracorporeal circuit in patients undergoing **continuous renal replacement therapy (CRRT)**, particularly in adult patients when systemic anticoagulation (such as heparin) is contraindicated due to bleeding risks. - The **mechanism of action** involves the use of citrate to chelate calcium ions in the extracorporeal circuit, thereby preventing coagulation locally without leading to systemic anticoagulation. The citrate is subsequently metabolized in the body, and a **separate systemic infusion of calcium is required** during use to prevent hypocalcemia. - Regiocit is intended **for extracorporeal use only and not for direct intravenous infusion**, and must be administered using pre-dilution mode with appropriate CRRT equipment. - The product is **not FDA-approved** but was authorized for emergency use by the US FDA during the COVID-19 pandemic, specifically for critically ill adult patients requiring CRRT. - Regiocit is manufactured by Baxter and distributed in multiple countries, including the US (under EUA during COVID-19), Europe, and Asia. - It is contraindicated in patients with severe liver failure, shock with muscle hypoperfusion, or hypersensitivity to any ingredient in the formulation[1][3][4][6][7][9].

Brand names
Regiocit
Other names
prismocitratecitrate replacement fluidsodium citrate solution

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