DEFENCATH 3000 [USP'U]/3mL
taurolidine and heparin · SOLUTION · CorMedix Inc.
DEFENCATH is a solution containing taurolidine and heparin at 3000 [USP'U]/3mL, taken intraluminal. Manufactured by CorMedix Inc..
Key Facts
- Brand Name
- DEFENCATH
- Generic Name
- taurolidine and heparin
- NDC Code (Product)
72990-103- Manufacturer
- CorMedix Inc.
- Strength
- 3000 [USP'U]/3mL
- Dosage Form
- SOLUTION
- Route
- INTRALUMINAL
- Marketing Status
- Application #
- NDA214520
- Drug Class
- Anti-coagulant [EPC]; Unfractionated Heparin [EPC]
- Marketing Start
- 04/09/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 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 [see Clinical Studies (14) ]. 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. LIMITED POPULATION: DEFENCATH is a combination of taurolidine, a thiadiazinane antimicrobial, and heparin, an anti-coagulant, 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. ( 1 ) 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION DEFENCATH is for instillation into CVCs only [see Indications and Usage (1) ]. DEFENCATH is not intended for systemic administration. Do not use DEFENCATH as a catheter lock flush product. Withdraw a sufficient volume of DEFENCATH catheter lock solution (CLS) from the vial using a sterile needle and syringe to fill the catheter lumens. Use 3 mL or 5 mL single-dose vial (depending on the volume of the catheter lumens) to instill DEFENCATH into each catheter lumen at the conclusion of each HD session for patients with kidney failure requiring chronic HD. Prior to initiation of the next HD session, DEFENCATH should be aspirated from the catheter and discarded. If DEFENCATH cannot be aspirated, continue with standard of care CVC preparation and flush with normal saline. If a catheter malfunction is suspected, appropriate standard of care measures should be instituted. Each DEFENCATH single-dose vial is designed for use with a single patient as a single instillation in the CVC. Discard any unused portion of DEFENCATH remaining in the vial. DEFENCATH is for instillation into CVCs only. ( 2 ) DEFENCATH is not intended for systemic administration. ( 2 ) Do not u…
Contraindications
4 CONTRAINDICATIONS DEFENCATH is contraindicated in patients with: Known heparin-induced thrombocytopenia (HIT) [see Warnings and Precautions (5.1) ] . Known hypersensitivity to taurolidine, heparin or the citrate excipient (components of DEFENCATH) or pork products [see Warnings and Precautions (5.2) ]. Known heparin-induced thrombocytopenia. ( 4 ) Known hypersensitivity to taurolidine, heparin or the citrate excipient (components of DEFENCATH), or pork products. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Heparin-Induced Thrombocytopenia [see Warnings and Precautions (5.1) ] Drug Hypersensitivity [see Warnings and Precautions (5.2) ] The most frequently reported adverse reactions occurring in greater than or equal to 2% of patients in Trial 1 using DEFENCATH as a CLS were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CorMedix Inc at 1-844-424-6345 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overview of the Safety Evaluation of DEFENCATH The safety of DEFENCATH was evaluated in a single, active-controlled, double-blind, randomized Phase 3 trial, LOCK-IT-100 (referred to as Trial 1), in adult patients with kidney failure receiving ch…
Frequently Asked Questions
What is DEFENCATH used for?
DEFENCATH contains taurolidine and heparin. It is a solution taken intraluminal. Consult your doctor for specific uses.
Is DEFENCATH a controlled substance?
DEFENCATH is not classified as a controlled substance by the DEA.
What is the generic name for DEFENCATH?
The generic name for DEFENCATH is taurolidine and heparin. There are no other listed brand versions of taurolidine and heparin.
What is the NDC code for DEFENCATH 3000 [USP'U]/3mL?
The NDC (National Drug Code) for DEFENCATH 3000 [USP'U]/3mL is 72990-103, listed by CorMedix Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)