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Government Health Agency News

FDA

Furoscix now approved in patients with CKD

March 13, 2025

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FDA expanded the indications of Furoscix (furosemide injection) to include treatment of edema in patients with chronic kidney disease.

Previously, Furoscix was approved for the treatment of edema in adults with chronic heart failure.

Safety

The most common adverse reactions in clinical trials were erythema, bruising, edema, and injection site pain.

Recommended dose

The single-use, On-body Infusor is pre-programmed to deliver 30 mg of furosemide over the first hour then 12.5 mg per hour for the subsequent 4 hours. Furoscix is not for chronic use and should be replaced with oral diuretics as soon as is practical.

Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.

Sources:

scPharmaceuticals. Furoscix (furosemide injection) [package insert]. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209988s003lbl.pdf Revised March 2025. Accessed March 12, 2025.

scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX® Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease. [News release]. scPharmaceuticals. 2025. https://ir.scpharmaceuticals.com/news-releases/news-release-details/scpharmaceuticals-announces-fda-approval-supplemental-new-drug-0

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