DEFENCATH

No pharmacokinetic studies were conducted because DEFENCATH is intended to be instilled into the catheter lumens at the conclusion of each HD session for patients with kidney failure requiring chronic HD. DEFENCATH is not intended for systemic administration [see Dosage and Administration (2) ] .

The efficacy and safety of DEFENCATH for reducing the incidence of CRBSI in patients with kidney failure receiving chronic HD was evaluated in LOCK-IT-100 (referred to as

Trial 1NCT02651428), a randomized, double-blind, active-controlled, multicenter trial. A total of 806 patients were randomized in a 1:1 ratio to receive either DEFENCATH or heparin (heparin sodium USP 1,000 units/mL, benzyl alcohol 9.45 mg/mL and sodium chloride 9.0 mg/mL) as a CLS. Enrollment in Trial 1 was not limited to patients with specific types of HD catheters. DEFENCATH or heparin was instilled into central venous H...

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 thrombocytopeni...

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 excipi...

Heparin-Induced Thrombocytopenia (HIT) : HIT was reported in Trial 1 at an incidence rate of 0.3% in patients using heparin, a component of DEFENCATH as a CLS. If HIT occurs, discontinue DEFENCATH and institute appropriate supportive measures. ( 5.1 ) Drug Hypersensitivity Reactions : Drug hypersensitivity reactions were reported in Trial 1 at an incidence rate of 0.5% in patients using heparin, a component of DEFENCATH, as a CLS. If a hypersensitivity reaction occurs, discontinue DEFENCATH and ...