The FDA approved a taurolidine and heparin (DefenCath) catheter lock solution for reducing the risk of bloodstream infections in patients on dialysis.
Approved under a special limited agency pathway, the antimicrobial and antifungal solution is only indicated for adults with kidney failure who are receiving chronic hemodialysis through a central venous catheter.
The phase III LOCK IT-100 trial, which included 795 maintenance hemodialysis patients, supported the product’s approval. When compared with the anticoagulant heparin alone, significantly fewer patients receiving the taurolidine-heparin solution had a catheter‐related bloodstream infection (8% vs 2%, respectively), representing a 71% (95% CI 38-86, P=0.0006) reduction in risk.
This was the third attempt at approval for the non-antibiotic solution, as it was already rejected twice by the FDA, the last time in August 2022 due to manufacturing issues.
Developer CorMedix explained that taurolidine is the key antimicrobial compound in the solution, derived from the naturally occurring amino acid taurine. In vitro studies demonstrated its antimicrobial activity against gram-positive and gram-negative bacteria — including antibiotic-resistant strains — plus mycobacteria and fungi.
It is only intended for use as a catheter lock solution and should not be injected into the body or used as a catheter lock flush product. The solution comes in a sterile, preservative-free, clear, aqueous-based solution in 3 mL and 5 mL dosages for use in a single patient one time.
According to the label, providers should withdraw a sufficient volume of the catheter lock solution from the vial using a sterile needle and syringe to fill the catheter lumens. Then depending on the volume of the catheter lumens, either the 3 mL or 5 mL vial should be used to instill the solution into each catheter lumen after each hemodialysis session. The solution should then be aspirated from the catheter and discarded, along with any unused solution in the vial.
It’s contraindicated for use in patients with heparin-induced thrombocytopenia or those with hypersensitivity to taurolidine, heparin, the citrate excipient, or pork products.
The most common adverse events, occurring in 2% or more patients, were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia.
In its approval announcement, CorMedix said it expects the product to be available in early 2024. The company “also intends to develop DefenCath as a catheter lock solution for use in other patient populations.”
Source link : https://www.medpagetoday.com/nephrology/esrd/107377
Publish date : 2023-11-15 14:07:31
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