Protect the central line
with demonstrated safety
Safety comparable with the standard of care (SOC) (heparin)
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.
Loss of catheter patency occurred more frequently with DefenCath than heparin (16% vs. 12%, respectively), including higher rates of thrombolytic agent use (12% vs. 8%, respectively).
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.
| Adverse reactions | DefenCath (n=398) n (%) | Heparin control (n=399) n (%) |
|---|---|---|
| Product issues | ||
| Hemodialysis catheter malfunctiona | 68 (17) | 47 (12) |
| Blood and lymphatic system disorders | ||
| Hemorrhage/ | 27 (7) | 34 (9) |
| Thrombocytopenia | 7 (2) | 4 (1) |
| Gastrointestinal disorders | ||
| Nauseac | 28 (7) | 44 (11) |
| Vomitingd | 24 (6) | 32 (8) |
| Nervous system disorders | ||
| Dizziness | 22 (6) | 16 (4) |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal chest paine | 11 (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
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Open formIMPORTANT 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.
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.