Defencath

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  • Bacterial infections
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Defencath Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Taurolidine 13.5mg/mL, heparin 1000 USP Units/mL; catheter lock soln for central venous catheter instillation; contains citric acid 26.1mg/mL; preservative-free.

    Pharmacological Class

    Thiadiazinane antimicrobial + anticoagulant.

    How Supplied

    Single-dose vials (3mL, 5mL)—10

    Storage

    Stored vials at a controlled room temperature of 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F). Do not freeze. 

    Vials must be stored in the commercial carton, prior to the instillation in central venous catheters. 

    Manufacturer

    CorMedix Inc.

    Generic Availability

    NO

    Mechanism of Action

    Taurolidine and its metabolites causes damage to microbial cell walls and inhibits adherence of microorganisms to biological surfaces.

    Heparin interacts with the naturally occurring plasma protein, Antithrombin III, to induce a conformational change, which markedly enhances the serine protease activity of Antithrombin III, thereby inhibiting the activated coagulation factors involved in the clotting sequence, particularly Xa and IIa. Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor.

    Defencath Indications

    Indications

    To reduce incidence of catheter-related bloodstream infections (CRBSI) in adults with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC).

    Limitations of Use

    Not established for populations other than adults with kidney failure receiving chronic hemodialysis through a CVC.

    Defencath Dosage and Administration

    Adult

    Not for systemic administration. Do not use as catheter lock flush. Instill 3mL or 5mL into each catheter lumen at the end of each hemodialysis (HD) session. Aspirate from the catheter and discard prior to next HD session. 

    Children

    Not established. 

    Defencath Contraindications

    Contraindications

    Heparin-induced thrombocytopenia. Hypersensitivity to pork products. 

    Defencath Boxed Warnings

    Not Applicable

    Defencath Warnings/Precautions

    Warnings/Precautions

    Discontinue if heparin-induced thrombocytopenia or hypersensitivity reaction occurs. 

    Defencath Pharmacokinetics

    See Literature

    Defencath Interactions

    Not Applicable

    Defencath Adverse Reactions

    Adverse Reactions

    Hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, thrombocytopenia; hypersensitivity reactions. 

    Defencath Clinical Trials

    Clinical Trials

    The approval of DefenCath was based on data from a double-blind, active-controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT02651428) that enrolled 806 patients with end-stage renal disease undergoing chronic hemodialysis at least 2 times per week. Study participants were randomly assigned to receive either Defencath (n=397) or heparin (n=398) as a catheter lock solution. 

    The primary outcome measure was the presence of CRBSI, defined as at least 1 positive blood culture from a peripheral site or bloodline sample, or either the arterial or venous catheter hub, with signs and symptoms of infection and no other apparent source of bloodstream infection. The final assessment was determined by a clinical adjudication committee (CAC).

    Results showed that DefenCath reduced the risk of CRBSI by 71% (95% CI, 38-86) compared with heparin (P =.0006). The incidence of CAC-adjudicated CRBSI was 2.3% (n=9) in the DefenCath group (event rate per 1000 catheter-days, 0.13 [95% CI, 0.07-0.26]) and 8% (n=32) in the heparin group (event rate per 1000 catheter-days, 0.46 [95% CI, 0.33-0.66]).

    Defencath Note

    Not Applicable

    Defencath Patient Counseling

    See Literature

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