DefenCath Now Available for Dialysis Patients to Prevent Catheter-Related Infections

DefenCath^® (taurolidine and heparin) catheter lock solution is now available for inpatient use to reduce the incidence of catheter-related bloodstream infections (CRBSI), in adult patients with kidney failure, receiving chronic hemodialysis through a central venous catheter (CVC). 

DefenCath is a combination of taurolidine, a thiadiazinane antimicrobial, and heparin, an anticoagulant. The treatment received approval in November 2023 based on data from the phase 3 LOCK-IT-100 trial (ClinicalTrials.gov Identifier: NCT02651428), which included 806 patients with end-stage renal disease undergoing chronic hemodialysis at least 2 times per week. Findings showed patients in the DefenCath treatment arm had a lower incidence of CRBSI events compared with those in the control arm.

The most frequently reported adverse reactions with DefenCath were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia. The prescribing information also includes warnings and precautions related to heparin-induced thrombocytopenia and drug hypersensitivity reactions. 

DefenCath is supplied as a sterile catheter lock solution in single-dose vials in the following strengths: 3mL containing taurolidine 40.5mg/3mL (13.5 mg/mL), and heparin 3000 USP Units/3mL (1000 USP Units/mL); and 5mL containing taurolidine 67.5mg/5mL (13.5mg/mL), and heparin 5000 USP Units/5mL (1000 USP Units/mL). 

DefenCath is intended for instillation into CVCs only and should not be used as a catheter lock flush product. Each single-dose vial is designed for use with a single patient as a single instillation in the CVC.

The safety and effectiveness of Defencath have not been established for use in populations other than adult patients with kidney failure receiving chronic hemodialysis through a CVC.

“Today opens a new chapter for health care providers, offering them an opportunity to reduce the risk of CRBSIs in a patient population already vulnerable due to underlying kidney failure,” said Joseph Todisco, CEO of CorMedix. “We are proud to provide an option for adult patients who face the risk of CRBSIs.”

According to the Company, the outpatient commercialization of DefenCath is expected to begin on July 1, 2024.