• Contemporary ClinicContemporary Clinic
  • OTC GuideOTC Guide
  • Pharmacy Times
  • PTCEPTCE
  • Pharmacist Moms GroupPharmacist Moms Group
News
All News
FDA Updates
Press Releases
Media
All Videos
Digital Detail
Independent Corner
Insights
Interviews
MEDcast
Medical World News
Microsites
Peer Exchange
Perfect Consult
Podcasts
Practice Pearls
Sponsored Webcast
Student Voices
Webinars/Webcasts
Conferences
Conference Coverage
Conference Listing
Publications
Pharmacy Times
Pharmacy Practice in Focus: Oncology
Pharmacy Practice in Focus: Health Systems
Pharmacy Careers
All Publications
About the Publications
Author Submission
Submit to Pharmacy Practice in Focus: Oncology
Submit to Pharmacy Practice in Focus: Health Systems
Become a Peer Reviewer
Supplements & Featured Publications
Clinical
503B Compounding Pharmacy
ADHD
Allergy
Alzheimer Disease
Anxiety
Asthma
Atopic Dermatitis
Biosimilars
Bipolar Disorder
Brain Health
Breast Cancer
C. Difficile
COPD
COVID-19
Cardiovascular Health
Cervical Cancer
Cholangiocarcinoma
Cholesterol
Chronic Kidney Disease
Chronic Lymphocytic Leukemia
Classical Hematology
Colorectal Cancer
Continuous Glucose Monitoring
Cough and Cold
Depression
Dermatology
Diabetes
Digestive Health
Dry Eye Disease
Epilepsy
Eye Care
Flu
Future of Pharmacy
Gastrointestinal Cancer
Gastrointestinal Health
Gout
HER2 Breast Cancer
HIV
Heart Failure
Hematology
Hepatitis/MASH
Immunization
Immuno-oncology
Immunoglobulins
Infectious Disease
Lung Cancer
Lymphoma
Macular Degeneration
Mental Health
Migraine
Movement Disorders
Multiple Myeloma
Multiple Sclerosis
Myelofibrosis
Neurology
Neutropenia
Osteoporosis
Ovarian Cancer
Pain Management
Parkinson Disease
Pediatrics
Pharmacy Heroes
Pharmacy Management
Pneumococcal
PrEP
Prostate Cancer
Psoriasis
Psoriatic Arthritis
Psychedelics
Reimbursement
Reproductive Health
Respiratory Syncytial Virus
Rheumatoid Arthritis
Schizophrenia
Shingles
Skin Cancer
Sleep
Travel Vaccines
Veterinary Pharmacy
Vitamins and Supplements
Weight Management
Women's Health
Events
Upcoming Events
Upcoming Webinars
CE
Resources
Clinical Forum
Cou-Co
Educated Patient
Information for the Pharmacist
Interactive Tools
Partners
Sponsored
Whiteboards
Subscribe
logo
Spotlight
Community/RetailHospitalOncologyPharmacy TechnicianStudent
Clinical Role
Community/RetailHospitalOncologyPharmacy TechnicianSpecialty PharmacyStudent
Clinical
CoronavirusBrain HealthCardiovascular HealthDermatologyDiabetesFluHeart FailureHepatitis/MASHImmunizationMigrainePneumococcalVitamins and Supplements
Supplement Spotlight
October 2023 Pharmacy Technician Edition
All News
FDA Updates
Press Releases
All Videos
Digital Detail
Independent Corner
Insights
Interviews
MEDcast
Medical World News
Microsites
Peer Exchange
Perfect Consult
Podcasts
Practice Pearls
Sponsored Webcast
Student Voices
Webinars/Webcasts
Conference Coverage
Conference Listing
Pharmacy Times
Pharmacy Practice in Focus: Oncology
Pharmacy Practice in Focus: Health Systems
Pharmacy Careers
All Publications
About the Publications
Author Submission
Submit to Pharmacy Practice in Focus: Oncology
Submit to Pharmacy Practice in Focus: Health Systems
Become a Peer Reviewer
Supplements & Featured Publications
503B Compounding Pharmacy
ADHD
Allergy
Alzheimer Disease
Anxiety
Asthma
Atopic Dermatitis
Biosimilars
Bipolar Disorder
Brain Health
Breast Cancer
C. Difficile
COPD
COVID-19
Cardiovascular Health
Cervical Cancer
Cholangiocarcinoma
Cholesterol
Chronic Kidney Disease
Chronic Lymphocytic Leukemia
Classical Hematology
Colorectal Cancer
Continuous Glucose Monitoring
Cough and Cold
Depression
Dermatology
Diabetes
Digestive Health
Dry Eye Disease
Epilepsy
Eye Care
Flu
Future of Pharmacy
Gastrointestinal Cancer
Gastrointestinal Health
Gout
HER2 Breast Cancer
HIV
Heart Failure
Hematology
Hepatitis/MASH
Immunization
Immuno-oncology
Immunoglobulins
Infectious Disease
Lung Cancer
Lymphoma
Macular Degeneration
Mental Health
Migraine
Movement Disorders
Multiple Myeloma
Multiple Sclerosis
Myelofibrosis
Neurology
Neutropenia
Osteoporosis
Ovarian Cancer
Pain Management
Parkinson Disease
Pediatrics
Pharmacy Heroes
Pharmacy Management
Pneumococcal
PrEP
Prostate Cancer
Psoriasis
Psoriatic Arthritis
Psychedelics
Reimbursement
Reproductive Health
Respiratory Syncytial Virus
Rheumatoid Arthritis
Schizophrenia
Shingles
Skin Cancer
Sleep
Travel Vaccines
Veterinary Pharmacy
Vitamins and Supplements
Weight Management
Women's Health
Upcoming Events
Upcoming Webinars
CE
Clinical Forum
Cou-Co
Educated Patient
Information for the Pharmacist
Interactive Tools
Partners
Sponsored
Whiteboards
Subscribe
Advertisement

CLINICAL ROLE -

Community/Retail
| Hospital
| Oncology
| Pharmacy Technician
| Student

News

Article

November 15, 2023

FDA Approves Defencath for Catheter-Related Infections for Those With Kidney Failure

Author(s):

Ashley Gallagher, Editor

Taurolidine and heparin (Defencath; CorMedix) is indicated to reduce catheter-related bloodstream infections for adults with kidney failure who are receiving chronic hemodialysis via central venous catheter

The FDA has approved taurolidine and heparin (Defencath; CorMedix), a catheter lock solution indicated to reduce catheter-related bloodstream infections for adults with kidney failure who are receiving chronic hemodialysis via central venous catheter (CVC), according to a press release from the agency. The approval is limited to this specific patient population.1

Human kidney cross section on scientific background | Image Credit: Crystal light - stock.adobe.com

Crystal light - stock.adobe.com

For patients with renal failure, hemodialysis is used to help filter waste and extra water from the bloodstream, often via a catheter. The filtration process can increase the risk of bloodstream infection, so reducing the risk of microbial infection through a patient’s catheter is important, according to the FDA.1

The combination of taurolidine and heparin is a sterile, preservation-free, aqueous-based solution available in 3 mL and 5 mL dosages. The 3 mL solution contains 40.5 mg/3 mL of taurolidine and 3000 USP units/3mL heparin. The 5 mL solution contains 67.5 mg/5 mL and 5000 USP units/5 mL, respectively.2 It is available in a single-dose vial that is designed for a single use and a single patient.1

The solution was proven to delay the time it took for patients to become infected with a catheter-related bloodstream infection (CRBSI), according to results of a phase 3 clinical trial, LOCK-IT-100. The findings showed that the combination had a 71% reduced risk of CRBSIs compared to the heparin comparator, the press release said.1 Furthermore, there were no significant differences between the combination and the comparator in time to catheter removal for any reason or loss of catheter patency.3

About The LOCK-IT-100 Trial

Trial Name: Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection

ClinicalTrials.gov Identifier: NCT02651428

Sponsor: CorMedix

Completion Date: October 2018

Investigators of the study enrolled 795 individuals with kidney failure who were undergoing maintenance hemodialysis via CVC, according to the study. Individuals were from 70 sites in the United States and were randomized 1:1 to received either the combination solution or heparin as a control at 1000 units/mL. The primary endpoint was assessed by a blinded Clinical Adjudication Committee. The safety was assessed by the Data and Safety Monitoring Board, recommending the trial end early for efficacy and no safety concerns, according to the study.

Taurolidine and heparin is intended for use as a catheter lock solution, which is not meant to be injected or used as a catheter lock flush product. Heparin-induced thrombocytopenia, an adverse drug reaction that can cause serious clotting in the veins and arteries, was reported in 0.3% of individuals in the clinical trial. Additionally, drug hypersensitivity reactions were reported in 0.5% of patients in the trial. If either of these reactions occur, the combination should be discontinued, and the appropriate medical treatment should be taken.1

The most frequent adverse reactions in 2% or greater of the trial participants included hemodialysis catheter malfunction, hemorrhaging, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia, according to the press release.1

Taurolidine and heparin was previously given fast track and qualified infectious disease product designations by the FDA.1 The safety and effectiveness of the drug has not been determined for other populations beyond this indication.2

Reference

  1. FDA approves new drug under special pathway for patients receiving hemodialysis. News release. FDA. November 15, 2023. Accessed 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
  2. Defencath. Prescribing information. CorMedix, 2023. Accessed November 15, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214520s000lbl.pdf
  3. Agarwal AK, Roy-Chaudhury P, Mounts P, Hurlburt E, Pfaffle A, Poggio EC. Taurolidine/Heparin Lock Solution and Catheter-Related Bloodstream Infection in Hemodialysis: A Randomized, Double-Blind, Active-Control, Phase 3 Study. Clin J Am Soc Nephrol. 2023;18(11):1446-1455. doi:10.2215/CJN.0000000000000278

Newsletter

Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights.

Subscribe Now!
Related Videos
Inflammation concept, inflammated human tissues 3d rendering - Image credit: picture-waterfall | stock.adobe.com
Austin Texas | Image credit: Kevin Ruck - stock.adobe.com
Pharmacy Times OPC
Related Content
Advertisement
Visualization of pulmonary hypertension | Image Credit: © Thirawat - stock.adobe.com
June 30th 2025

Pulmonary Hypertension Associated With Increased Risk of Progression in Patients With Myeloproliferative Neoplasms

Alexandra Gerlach, Associate Editor
Pharmacy Times, Pharmacy Focus Oncology Edition
June 27th 2025

Allen's Story: The Promising Potential of Intratumoral Immunotherapy

Alexandra Gerlach, Associate Editor
Respiratory Virus Genetic Material Micrograph - Image credit: GOLVR | stock.adobe.com
June 30th 2025

Study Sheds Light on Impact of Vaccination, Infection on Anti-RSV IgG Levels

Kennedy Ferruggia, Assistant Editor
Concierge Pharmacy's Role in Cardio-Kidney-Metabolic Health Care
June 17th 2025

Concierge Pharmacy's Role in Cardio-Kidney-Metabolic Health Care

Craig Beavers, PharmD, FACC, FAHA, FCCP, BCCP, BCPSAQ Cardiology, CACP Aislinn Antrim, Managing Editor
PCAB Accreditation as a Safety Net: GLP-1 Demand and the Spotlight on Compounding Standards
June 27th 2025

PCAB Accreditation as a Safety Net: GLP-1 Demand and the Spotlight on Compounding Standards

Karen Spano, RPh, HDDP
Real-World Evidence Helps Accelerate Formulary Decisions for Biologics
June 27th 2025

Real-World Evidence Helps Accelerate Formulary Decisions for Biologics

Muhammad Cheema, PharmD, MPBA
Related Content
Advertisement
Visualization of pulmonary hypertension | Image Credit: © Thirawat - stock.adobe.com
June 30th 2025

Pulmonary Hypertension Associated With Increased Risk of Progression in Patients With Myeloproliferative Neoplasms

Alexandra Gerlach, Associate Editor
Pharmacy Times, Pharmacy Focus Oncology Edition
June 27th 2025

Allen's Story: The Promising Potential of Intratumoral Immunotherapy

Alexandra Gerlach, Associate Editor
Respiratory Virus Genetic Material Micrograph - Image credit: GOLVR | stock.adobe.com
June 30th 2025

Study Sheds Light on Impact of Vaccination, Infection on Anti-RSV IgG Levels

Kennedy Ferruggia, Assistant Editor
Concierge Pharmacy's Role in Cardio-Kidney-Metabolic Health Care
June 17th 2025

Concierge Pharmacy's Role in Cardio-Kidney-Metabolic Health Care

Craig Beavers, PharmD, FACC, FAHA, FCCP, BCCP, BCPSAQ Cardiology, CACP Aislinn Antrim, Managing Editor
PCAB Accreditation as a Safety Net: GLP-1 Demand and the Spotlight on Compounding Standards
June 27th 2025

PCAB Accreditation as a Safety Net: GLP-1 Demand and the Spotlight on Compounding Standards

Karen Spano, RPh, HDDP
Real-World Evidence Helps Accelerate Formulary Decisions for Biologics
June 27th 2025

Real-World Evidence Helps Accelerate Formulary Decisions for Biologics

Muhammad Cheema, PharmD, MPBA
Consent Preferences
About Us
Clinical Forums
Advertise
Contact Us
Editorial Staff
Privacy Policy
Terms & Conditions
Do Not Sell My Information
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.