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Prescribing Information

Protect the central line
with demonstrated safety

Safety comparable with the standard of care (SOC) (heparin)

This was demonstrated across a large and diverse chronic HD-CVC patient population reflective of real-world patients in the US.1,2

In LOCK-IT-1001:

The safety of DefenCath
was evaluated in797 patients(398 DefenCath vs 399 heparin control)

over a mean duration of

173 days(range, 4 to 863 days)

Adverse reactions were similar between DefenCath® (taurolidine and heparin) catheter lock solution and heparin control1

Serious adverse reactions occurred in 40% (159/398) of patients receiving DefenCath as a CLS and 42% (167/399) of patients receiving heparin as a CLS.1 Adverse reactions leading to death occurred in 5% (18/398) patients in the DefenCath arm and 5% (21/399) of patients in the heparin arm.1

Common adverse reactions1:

Adverse reactions were reported in 79% (314/398) of patients using DefenCath and 79% (315/399) of patients using heparin control.

Discontinuations1:

Adverse reactions leading to discontinuation of study drug occurred in 17% (69/398) of patients in the DefenCath arm and 18% (72/399) of patients in the heparin arm.

Selected adverse reactions occurring in ≥2% of patients receiving DefenCath or
heparin control1

Adverse
reactions
DefenCath (n=398)
n (%)
Heparin control (n=399)
n (%)
Product issues
Hemodialysis catheter malfunctiona68 (17)47 (12)
Blood and lymphatic system disorders
Hemorrhage/bleedingb27 (7)34 (9)
Thrombocyto­penia7 (2)4 (1)
Gastrointesti­nal disorders
Nauseac28 (7)44 (11)
Vomitingd24 (6)32 (8)
Nervous system disorders
Dizziness22 (6)16 (4)
Musculoskel­etal and connective tissue disorders
Musculoskel­etal chest paine11 (3)7 (2)

aGrouped term includes device malfunction.

bGrouped term includes: hematoma/hemorrhage, intracranial hemorrhage, arteriovenous graft or fistula site hemorrhage, catheter site hematoma/hemorrhage, cerebral/cerebellar hemorrhage, eye/conjunctival hemorrhage, gastrointestinal hemorrhage, hematuria, hemobilia, hemoptysis, renal hematoma, vaginal/uterine hemorrhage.

cGrouped term includes nausea and procedural nausea.

dGrouped term includes vomiting and procedural vomiting.

eGrouped term Includes non-cardiac chest pain, musculoskeletal chest pain, chest discomfort.

Other adverse reactions1:

Clinically significant adverse reactions that occurred in fewer than 1% of patients receiving DefenCath in Trial 1 are listed below:

  • Metabolism and Nutrition Disorders: Hypocalcemia
  • Nervous System Disorders: Dysgeusia
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
Next: Dosing and Administration
Can be utilized with commonly used HD‑CVCs.
See how to use

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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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