Is DefenCath approved by the FDA?
DefenCath was approved by the U.S. Food and Drug Administration on November 15, 2023.
What is DefenCath?
DefenCath is a combination catheter lock solution (CLS) containing taurolidine and heparin. It is used to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure who are receiving chronic hemodialysis (HD) through a central venous catheter (CVC).
How Does DefenCath Work?
- Taurolidine: An antimicrobial agent that damages microbial cell walls and prevents microorganisms from adhering to biological surfaces. It is effective against common Gram-positive and Gram-negative organisms, as well as fungi.
- Heparin: An anticoagulant that prevents blood clot formation by enhancing the activity of Antithrombin III, which inhibits certain clotting factors. Heparin does not dissolve existing clots but prevents the formation of new stable fibrin clots.
Clinical Efficacy
DefenCath was shown to reduce the risk of CRBSIs by up to 71% in a Phase 3 clinical study, making it the first and currently only FDA-approved antimicrobial CLS in the U.S.
Warnings and Precautions
- Limited Use: Indicated only for patients with kidney failure receiving chronic HD through a CVC. The safety and effectiveness for other populations have not been established.
- Not for Flush Use: Do not use as a catheter lock flush product.
- Hypersensitivity Reactions: Do not use in patients with known heparin-induced thrombocytopenia or hypersensitivity to taurolidine, heparin, citrate excipient, or pork products. Hypersensitivity reactions to heparin have been reported at a rate of 0.5%.
- Heparin-Induced Thrombocytopenia (HIT): Reported at an incidence rate of 0.3%. If HIT occurs, discontinue use and provide appropriate supportive measures.
Before Taking DefenCath
Inform your doctor if you have had any hypersensitivity reactions to heparin, taurolidine, citrate excipients, or pork products, or if you have a history of thrombocytopenia. DefenCath should not be used if you do not have kidney failure or are not receiving hemodialysis through a CVC.
Administration
DefenCath is administered by a healthcare provider and is intended only for instillation into central venous catheters. It is not for systemic administration.
Side Effects
The most frequently reported side effects (occurring in 2% or more of patients) include:
- Hemodialysis catheter malfunction
- Hemorrhage/bleeding
- Nausea
- Vomiting
- Dizziness
- Musculoskeletal chest pain
- Thrombocytopenia
For suspected allergic reactions, contact CorMedix Inc. at 1-844-424-6345 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
No formal drug interaction studies have been conducted.
Ingredients
- Active: Taurolidine and heparin
- Inactive: Citric acid anhydrous (26.1 mg/mL), with possible pH adjustments using hydrochloric acid and/or sodium hydroxide.
Available Strengths
- 3 mL vials containing taurolidine 40.5 mg (13.5 mg/mL) and heparin 3,000 USP Units (1,000 USP Units/mL)
- 5 mL vials containing taurolidine 67.5 mg (13.5 mg/mL) and heparin 5,000 USP Units (1,000 USP Units/mL)
Storage
Store DefenCath in the original carton at a controlled room temperature of 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C to 30°C (59°F to 86°F). Do not freeze.
Conclusion
DefenCath, approved by the FDA on November 15, 2023, is a significant advancement in reducing CRBSI in patients with kidney failure undergoing chronic hemodialysis through a central venous catheter. Its combination of taurolidine and heparin provides both antimicrobial and anticoagulant benefits, enhancing patient safety and treatment efficacy.
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