Taurolidine and heparin

(DefenCath®)

DefenCath®

Drug updated on 10/21/2024

Dosage FormCatheter lock solution (central venous catheter; taurolidine 40.5 mg/3 mL [13.5 mg/mL], and heparin 3,000 USP Units/3 mL [1,000 USP Units/mL]; taurolidine 67.5 mg/5 mL [13.5 mg/mL], and heparin 5,000 USP Units/5 mL [1,000 USP Units/mL])
Drug ClassAnti-coagulants
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC).

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Summary
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  • This summary is based on the review of two randomized controlled trial(s). [1-2]
  • In the LOCK IT-100 trial, taurolidine/heparin significantly reduced the risk of catheter-related bloodstream infections (CRBSIS) compared to heparin alone, with 2% CRBSIs in the taurolidine/heparin group versus 8% in the heparin group. The hazard ratio was 0.29 (95% CI, 0.14 to 0.62), representing a 71% reduction in CRBSI risk (P < 0.001).
  • In a trial involving high-risk neutropenic hematologic patients, taurolidine-citrate-heparin showed a trend toward reduced bacterial colonization compared to placebo (4.1% vs. 10.1%, RR = 0.41, 95% CI = 0.11 to 1.52), but this difference was not statistically significant. No significant differences were observed in secondary outcomes such as CRBSI incidence or catheter removal.
  • In the LOCK IT-100 trial, the safety profile of taurolidine/heparin was comparable to heparin, with most treatment-emergent adverse events being mild or moderate. The Data and Safety Monitoring Board recommended early termination of the trial for efficacy, with no safety concerns.
  • In the trial involving hematologic patients, no adverse events related to the administration of the taurolidine-citrate-heparin lock solution were reported, indicating a favorable safety profile compared to placebo.
  • The LOCK IT-100 trial involved adults with kidney failure undergoing maintenance hemodialysis via CVC and showed that taurolidine/heparin significantly reduced the risk of catheter-related bloodstream infections (CRBSIS) compared to heparin alone. The trial involving hematologic patients included high-risk neutropenic patients with nontunneled CVCs, and while taurolidine-citrate-heparin showed a trend towards less bacterial colonization, it was not statistically significant. No significant differences in effectiveness were observed among subgroups within these populations.

Product Monograph / Prescribing Information

Document TitleYearSource
DefenCath (taurolidine and heparin) Prescribing Information.2023CorMedix, Inc., Berkeley Heights, NJ

Randomized Controlled Trials