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Prescribing Information

Protect the
central line

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.

Introducing DefenCath

The first and only FDA-approved catheter lock solution (CLS) proven to significantly reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients receiving chronic hemodialysis (HD) with central venous catheters (CVC).1

DefenCath reduces the incidence of CRBSIs before infections can start, so you can protect the entire length of the lumen.1

PROVEN EFFICACY

The first FDA‑approved CLS proven to reduce the incidence of CRBSIs by 71%1

Studied in the largest trial to date in the US in patients receiving hemodialysis via CVC. DefenCath has proven to help reduce CRBSIs.1,2

Explore study design and results

HOW DEFENCATH WORKS

A first-in-class CLS with taurolidine + heparin1

DefenCath is the only FDA-approved solution that protects the CVC lumen pathway with antimicrobial activity.1

Explore MOA

SAFETY

Trust in a demonstrated
safety profile

In a pivotal clinical study, DefenCath was shown to have a similar safety profile as standard‑of‑care (SOC) heparin, and risk of adverse events were similar1,3

View safety profile

USING DEFENCATH

Can be utilized with commonly used HD-CVCs

DefenCath, with refrigeration-free storage, can be utilized with commonly used HD-CVCs and is administered similarly to standard-of-care (heparin).1,3

Learn how to use

DEFENCATH RESOURCE PORTAL

Get information and helpful downloads about
DefenCath®
(taurolidine and heparin)
catheter lock solution

Discover resources and tools for protocol adoption, implementation best practices, ordering information, reimbursement, and more.

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.0000000000278 3. Arechabala MC, Catoni MI, Claro JC, et al. Antimicrobial lock solutions for preventing catheter-related infections in haemodialysis. Cochrane Database Syst Rev. 2018;(4):CD010597. doi:10.1002/14651858.CD010597.pub2

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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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