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Indication 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.
Important Safety Information
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 www.fda.gov/medwatch.
Please see the full Prescribing Information.