Taurolidine

Heparin Heparin interacts with the naturally occurring plasma protein, Antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin III, thereby inhibiting the activated coagulation factors involved in the clotting sequence, particularly Xa and IIa. Small amounts of heparin inhibit Factor Xa, and larger amounts inhibit thrombin (Factor IIa).

• LIMITED POPULATION: DEFENCATH ® is 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). This drug is indicated for use in a limited and specific population of patients [see Clinical Studies (14) ].

• DEFENCATH is contraindicated in patients with: Known heparin-induced thrombocytopenia (HIT) [see Warnings and Precautions (5.1) ] . Known hypersensitivity to taurolidine, heparin or the citrate excipient (components of DEFENCATH) or pork products [see Warnings and Precautions (5.2) ].contraindicated

DEFENCATH is for instillation into CVCs only [see Indications and Usage (1) ]. DEFENCATH is not intended for systemic administration. Do not use DEFENCATH as a catheter lock flush product. Withdraw a sufficient volume of DEFENCATH catheter lock solution (CLS) from the vial using a sterile needle and syringe to fill the catheter lumens. Use 3 mL or 5 mL single-dose vial (depending on the volume of the catheter lumens) to instill DEFENCATH into each catheter lumen at the conclusion of each HD session for patients with kidney failure requiring chronic HD. Prior to initiation of the next HD session, DEFENCATH should be aspirated from the catheter and discarded. If DEFENCATH cannot be aspirated, continue with standard of care CVC preparation and flush with normal saline. If a catheter malfunction is suspected, appropriate standard of care measures should be instituted. Each DEFENCATH single-dose vial is designed for use with a single patient as a single instillation in the CVC. Discard any unused portion of DEFENCATH remaining in the vial. DEFENCATH is for instillation into CVCs only. ( 2 ) DEFENCATH is not intended for systemic administration. ( 2 ) Do not use DEFENCATH as a catheter lock flush product. ( 2 ) Withdraw a sufficient volume of DEFENCATH catheter lock solution (CLS) from the vial using a sterile needle and syringe to fill the catheter lumens. ( 2 ) Use 3 mL or 5 mL single dose vial (depending on the volume of the catheter lumens) to instill DEFENCATH into each catheter lumen at the conclusion of each HD session.

Heparin-Induced Thrombocytopenia (HIT) : HIT was reported in Trial 1 at an incidence rate of 0.3% in patients using heparin, a component of DEFENCATH as a CLS. If HIT occurs, discontinue DEFENCATH and institute appropriate supportive measures. ( 5.1 ) Drug Hypersensitivity Reactions : Drug hypersensitivity reactions were reported in Trial 1 at an incidence rate of 0.5% in patients using heparin, a component of DEFENCATH, as a CLS. If a hypersensitivity reaction occurs, discontinue DEFENCATH and institute appropriate supportive measures. ( 5.2 ) 5.1 Heparin-Induced Thrombocytopenia Heparin-induced thrombocytopenia (HIT) was reported at an incidence rate of 0.3% in Trial 1 in patients using heparin, a component of DEFENCATH, as a CLS. If HIT occurs, discontinue DEFENCATH and institute appropriate supportive measures [see Contraindications (4) ] . 5.2 Drug Hypersensitivity Drug hypersensitivity reactions were reported at an incidence rate of 0.5% in Trial 1 in patients using heparin, a component of DEFENCATH, as a CLS. If a hypersensitivity reaction occurs, discontinue DEFENCATH and institute appropriate supportive measures [see Contraindications (4) ] .

The following clinically significant adverse reactions are described elsewhere in the labeling: Heparin-Induced Thrombocytopenia [see Warnings and Precautions (5.1) ] Drug Hypersensitivity [see Warnings and Precautions (5.2) ] The most frequently reported adverse reactions occurring in greater than or equal to 2% of patients in Trial 1 using DEFENCATH as a CLS were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CorMedix Inc at 1-844-424-6345 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overview of the Safety Evaluation of DEFENCATH The safety of DEFENCATH was evaluated in a single, active-controlled, double-blind, randomized Phase 3 trial, LOCK-IT-100 (referred to as Trial 1), in adult patients with kidney failure receiving chronic HD through a CVC. In Trial 1, the safety population was comprised of 797 patients with 398 patients using DEFENCATH as a CLS and 399 using heparin as a CLS. Patients used DEFENCATH as a CLS for a mean duration of 173 days, and a range of 4 to 863 days.

8.1 Pregnancy Risk Summary DEFENCATH is not intended for systemic administration. It is intended for use as a CLS in patients with kidney failure requiring chronic HD; therefore, maternal use is not expected to result in fetal exposure to the drug [see Dosage and Administration (2) ] . No animal reproduction study was conducted with DEFENCATH. 8.2 Lactation Risk Summary DEFENCATH is not intended for systemic administration. It is intended for use as a CLS in patients with kidney failure requiring chronic HD; therefore, breastfeeding is not expected to result in exposure of the infant to DEFENCATH [see Dosage and Administration (2) ] . 8.4 Pediatric Use The safety and effectiveness of DEFENCATH have not been established in pediatric patients. There are no available data on DEFENCATH use in pediatric patients. 8.5 Geriatric Use There were 327 patients 65 years of age and older in Trial 1 [see Clinical Studies (14) ] . Of the total number of patients using DEFENCATH in this study, 162 (41%) were 65 years of age and older, while 64 (16%) were 75 years of age and older. No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.

Metabolism

No pharmacokinetic studies were conducted because DEFENCATH is intended to be instilled into the catheter lumens at the conclusion of each HD session for patients with kidney failure requiring chronic HD. DEFENCATH is not intended for systemic administration [see Dosage and Administration (2) ] .

• Nov 15, 2023NDANDA214520Cormedix

1. 1Drug Hypersensitivity338%
2. 2Drug Ineffective338%
3. 3Device Malfunction225%
4. 4Complication Associated With Device113%
5. 5Device Occlusion113%
6. 6Dialysis113%
7. 7Hypoxia113%
8. 8Infusion Related Reaction113%
9. 9Paraesthesia Oral113%
10. 10Pulmonary Embolism113%
11. 11Pulse Absent113%
12. 12Seizure113%
13. 13Sepsis113%
14. 14Thrombosis113%

The 10 most recently updated of 32 ClinicalTrials.gov registrations naming Taurolidine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)
  Recruiting · Phase 3 · Interventional · 200 enrolled · CorMedix
  NCT06822426updated 2026-05-20
• Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
  Recruiting · Phase 4 · Interventional · 36 enrolled · CorMedix
  NCT06714864updated 2026-05-19
• Expanded Access Program for Patients at Risk for Catheter-related Infections Who Are Not Eligible for DefenCath® Clinical Trials
  Available · Expanded access · CorMedix
  NCT06707480updated 2026-05-18
• Neonatal Catheter Lock for Infection Prevention
  Not yet recruiting · Interventional · 576 enrolled · University of Turin, Italy
  NCT07585188updated 2026-05-13
• Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology
  Recruiting · Interventional · 148 enrolled · Institut Curie
  NCT05781295updated 2026-02-20
• Efficacy of Taurolidine Containing Lock Solution for Prevention of Central Venous Catheter Infection in ICU Patients
  Completed · Interventional · 120 enrolled · Tanta University
  NCT07366372updated 2026-01-26
• Use of a Taurolidine Containing Antimicrobial Wash to Reduce Prosthetic Device Infection After Trauma Surgery
  Active not recruiting · Observational · 28 enrolled · University of Kiel
  NCT06919770updated 2026-01-20
• Survey of Practices Regarding the Use of Taurolidine Lock Solutions in Patients With Insertion of a Peripherally Inserted Central Catheter (PICC) in a Vascular Access Unit
  Not yet recruiting · Observational · 45 enrolled · University Hospital, Grenoble
  NCT07259421updated 2025-12-02
• Antimicrobial Locks for Hemodialysis Catheter Infections
  Completed · Phase 2 · Interventional · 100 enrolled · Oman Ministry of Health
  NCT07074821updated 2025-07-20
• Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection
  Completed · Phase 3 · Interventional · 806 enrolled · CorMedix
  NCT02651428updated 2025-02-25

Frequently asked questions

How does Taurolidine work?

Heparin Heparin interacts with the naturally occurring plasma protein, Antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin III, thereby inhibiting the activated coagulation factors involved in the clotting sequence, particularly Xa and IIa. Small amounts of heparin inhibit Factor Xa, and larger amounts inhibit thrombin (Factor IIa).

What is Taurolidine used for?

According to FDA labeling, Taurolidine carries indications including: LIMITED POPULATION: DEFENCATH ® is 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). This drug is indicated for use in a limited and specific population of patients [see Clinical Studies (14) ].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Taurolidine?

Taurolidine is classified as Antiinfectives.

What are the brand names for Taurolidine?

Taurolidine is marketed under brand names including Defencath.

What are the contraindications for Taurolidine?

Taurolidine labeling lists contraindications including: DEFENCATH is contraindicated in patients with: Known heparin-induced thrombocytopenia (HIT) [see Warnings and Precautions (5.1) ] . Known hypersensitivity to taurolidine, heparin or the citrate excipient (components of DEFENCATH) or pork products [see Warnings and Precautions (5.2) ].. Always consult the full prescribing information and a clinician.