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Prescribing Information

Protect the central line from end-to-end

with a first-in-class catheter lock solution (CLS)

DefenCath has been shown to stop pathogens along the entire length of the central venous catheter (CVC) lumen, delivering end-to-end protection with no known antimicrobial resistance.1-3†

No known risk of antimicrobial resistance shown in in vitro studies.

DefenCath packaging

Not actual size.

What is DefenCath® (taurolidine and heparin) catheter lock solution?

DefenCath is the first and only CLS with taurolidine and heparin1,2

It is the only CLS with potent, antimicrobial activity against a broad spectrum of harmful and drug-resistant pathogens that can form throughout the CVC.1-3

The following in vitro data are available but their clinical significance is unknown. Taurolidine has been shown to be active against most isolates of the following microorganisms1:

Pathogens include gram-positive bacteria: Staphylococcus aureus (including methicillin-sensitive Staphylococcus aureus [MSSA] and methicillin-resistant Staphylococcus aureus [MRSA]), Staphylococcus epidermidis, and Enterococcus faecalis; gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens; and fungi: Candida albicans and Candida glabrata.

A CLS with taurolidine + heparin

Taurolidine acts as a broad-spectrum antimicrobial, by1,3§:

  • employing a non-specific mechanism of action that causes damage to microbial cell walls1
  • has anti-adherence properties, inhibiting microbial adherence to biologic surfaces inside the central line

Heparin is an anticoagulant that helps with maintaining catheter line patency.1,4

Together, only DefenCath combines antimicrobial with anticoagulant activity—for a unique catheter lock solution that reduces the risk of catheter-related bloodstream infections (CRBSI)-causing bacteria and fungi with no known antimicrobial resistance.1,2§

For more information on the molecular structure of taurolidine, please see the full Prescribing Information.

Molecular structure of taurolidine1

Molecular structure of heparin sodium1

The following in vitro data are available but their clinical significance is unknown. Taurolidine has been shown to be active against most isolates of the following microorganisms1:

§Pathogens include gram-positive bacteria: Staphylococcus aureus (including methicillin-sensitive Staphylococcus aureus [MSSA] and methicillin-resistant Staphylococcus aureus [MRSA]), Staphylococcus epidermidis, and Enterococcus faecalis; gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens; and fungi: Candida albicans and Candida glabrata.

DefenCath® (taurolidine and heparin) catheter lock solution has a nonspecific mechanism of action, with broad in vitro|| activity against most isolates of the following common pathogens1:

||Clinical significance is unknown.

Gram-positive bacteria:

  • Staphylococcus aureus (including methicillin-sensitive Staphylococcus aureus (MSSA) and methicillin-resistant Staphylococcus aureus (MRSA))
  • Staphylococcus epidermidis
  • Enterococcus faecalis

Gram-negative bacteria:

  • Escherichia coli
  • Klebsiella pneumoniae
  • Pseudomonas aeruginosa
  • Serratia marcescens

Fungi

  • Candida albicans
  • Candida glabrata
References: 1. DefenCath® (taurolidine and heparin) catheter lock solution Prescribing Information, CorMedix, Berkeley Heights, New Jersey. 2. 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 Nov 1;18(11):1446-1455. doi:10.2215/CJN.0000000000000278 3. Data on file, CorMedix Inc. 4. U.S. Food and Drug Administration. Product Classification. Updated March 25, 2024. Accessed March 28, 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NZW
Next: Safety
DefenCath delivers a demonstrated safety profile.
View safety profile

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IMPORTANT SAFETY INFORMATION (cont'd)

CONTRAINDICATIONS

DefenCath is contraindicated in patients with:

  • Known heparin-induced thrombocytopenia (HIT).
  • Known hypersensitivity to taurolidine, heparin or the citrate excipient (components of DefenCath), or pork products.

WARNINGS AND PRECAUTIONS

  • Heparin-Induced Thrombocytopenia (HIT): HIT was reported in patients using heparin, a component of DefenCath, as a catheter lock solution. If HIT occurs, discontinue DefenCath and institute appropriate supportive measures.
  • Drug Hypersensitivity: Drug hypersensitivity reactions have been reported in patients using heparin, a component of DefenCath, as a catheter lock solution. If a hypersensitivity reaction occurs, discontinue DefenCath and institute appropriate supportive measures.

ADVERSE REACTIONS

The most frequently reported adverse reactions occurring in ≥2% of patients using DefenCath as a CLS were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia.

To report SUSPECTED ADVERSE REACTIONS, contact CorMedix Inc at 1-844-424-6345 or FDA at 1-800-FDA-1088 or .

Indications and Usage

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.

Limitations of Use
The safety and effectiveness of DefenCath have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC.

Please see the full Prescribing Information.

Proven EfficacyHow DefenCath WorksSafetyDosing and AdministrationOrdering DefenCath
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