FDA Approves Defencath to Reduce Catheter Bloodstream Infections in Adults Receiving Hemodialysis

The U.S. Food and Drug Administration (FDA) approved Defencath (taurolidine and heparin) on November 15 to decrease catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC).

Defencath, a sterile, preservative-free, clear, aqueous-based catheter lock solution, is available in 3mL and 5mL doses. Three mL of Defencath contains taurolidine 40.5 mg/3 mL and heparin 3,000 USP units/3 mL, and 5 ml of Defencath includes 67.5 mg/5 mL and heparin 5,000 USP/5 mL).

Renal failure leads to the kidney’s inability to get rid of waste products and extra water from the body. To repair the kidney, patients use the treatment options of either hemodialysis, peritoneal dialysis, or kidney transplant. Hemodialysis filters wastes and extra water from the blood, often requiring a catheter for the filtration process. The catheter can lead to a risk of bloodstream infection.

Investigators studied Defencath in a single, randomized, active-controlled phase 3 clinical trial of 806 patients. The drug delayed the time it took for the catheter to get a bloodstream infection. Defencath had a 71% risk reduction in a bloodstream infection, compared to the heparin comparator arm (95% CI, 38% - 86%; P = .0006).

“Defencath is intended for use as a catheter lock solution only and is not meant to be injected into the body or used as a catheter lock flush product,” the FDA said. “Each Defencath single-dose vial is designed for use with a single patient as a single instillation in the CVC.”

The FDA warned Defencath could have a heparin-induced thrombocytopenia (HIT) adverse drug reaction, which may lead to life-threatening clotting in veins and arteries. In the study, 0.3% of patients experienced the condition. The FDA advises people if HIT occurs, to stop using Defencath and to begin other medical treatment.

Defencath can also have drug hypersensitivity reactions, reported in 0.5% of patients in the study. If this occurred, FDA wrote Defencath should be discontinued.

Other side effects include hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia. Defencath is only intended for adult patients with kidney failure requiring chronic hemodialysis, so it is not intended for patients with pregnancy, lactation, or pediatric use.

^References

^{FDA Approves New Drug Under Special Pathway for Patients Receiving Hemodialysis. U.S. Food & Drug Administration. November 15, 2023. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-drug-under-special-pathway-patients-receiving-hemodialysis?utm_medium=email&utm_source=govdelivery. Accessed November 15, 2023.}