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Prescribing Information

DefenCath works with the most commonly used HD‑CVCs

and features: ready to use 3mL single-use vials, refrigeration-free storage and seamless workflow integration

DefenCath is administered similarly to standard-of-care (heparin).1,2

Available in single-dose 3 mL vials1

DefenCath is available as a sterile, preservative-free, clear, aqueous-based solution that consists of taurolidine 40.5 mg/3 mL (13.5 mg/mL) and heparin 3,000 USP Units/3 mL (1,000 USP Units/mL).

DefenCath packaging and bottle

Not actual size.

Administration is similar to current CLS practices

Important reminders while administering:

  • DefenCath is for instillation in CVCs only1
  • DefenCath is not intended for systemic administration1
  • Do not use DefenCath as a catheter lock flush product1
  • DefenCath must be aspirated from the catheter and discarded prior to the initiation of the next HD session1

Preparing for administration

Before accessing the catheter, follow the CDC's for preparing the catheter hubs prior to catheter access.

The following steps outline the administration process from syringes:

STEP 1.

Withdraw a sufficient volume of DefenCath from the vial using a sterile needle and syringe to fill the catheter lumens1

STEP 2.

Slowly instill DefenCath into each catheter lumen1

STEP 3.

Discard any unused portion of DefenCath remaining in the vial.1

Please see full Prescribing Information for complete instructions.

How DefenCath®
(taurolidine and heparin) catheter lock solution is supplied and stored

Single-dose vials1

  • DefenCath is available in 3 mL vials and is supplied in cartons containing 10 vials.
  • Each vial contains a sterile, preservative-free, clear aqueous-based solution for instillation in central venous catheters.

Storage requirements1

  • DefenCath vials must be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F).
  • Do not freeze.
  • Vials must be stored in the commercial carton, prior to the instillation in CVCs.

Please see full Prescribing Information for complete instructions.

References: 1. DefenCath® (taurolidine and heparin) catheter lock solution Prescribing Information, CorMedix, Berkeley Heights, New Jersey. 2. 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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MAT-0015 06/24

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