HEPARIN/ TAUROLIDINE INJ,SOLN
Clinical Criteria Summary
Indication
- Reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients receiving chronic hemodialysis (HD) via a central venous catheter (CVC)
- Approved under the Limited Population Pathway for Antimicrobial/Antifungal Drugs (LPAD)
Dosage & Administration
- Instilled into the catheter lumen after each dialysis session
- Removed/aspirated from the catheter prior to subsequent hemodialysis sessions
- Not intended for systemic administration
- Should not be used as a catheter lock flush product
Patient Population
- Adult patients receiving intermittent HD (>= 2 per week) via a permanent tunneled cuffed silicone or polyurethane CVC
- Excludes patients who have received antibiotics, thrombolytics, or are immunosuppressed
- Requires life expectancy > 6 months
Contraindications & Warnings
- Known heparin induced thrombocytopenia (HIT)
- Known hypersensitivity to taurolidine, heparin, the citrate component of the drug, or pork products
- Discontinue if HIT occurs and institute supportive care
Formulations
- 3mL CLS in a single-use vial containing 40.5mg/3000 Units of taurolidine and heparin, respectively
- Under Review: 5mL CLS in a single-use vial containing 67.5mg and 5000 Units of taurolidine and heparin, respectively
VHA Use Considerations
- Demonstrated fewer CRBSIs than heparin alone but has not been compared head-to-head versus a 4% citrate solution (which is routinely used and has inherent antimicrobial properties)
- Taurolidine containing CLS have been studied off-label in other populations (e.g., Oncology, GI TPN requiring patients), but VHA requests to date have been infrequent; potential for off-label use is difficult to predict