Version May 2024
Catheter-related bloodstream infection, prevention:
Note: Only indicated for patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter.
Intracatheter: Instill a sufficient volume of solution (containing heparin 1,000 units/mL and taurolidine 13.5 mg/mL) into each catheter lumen at the conclusion of each HD session; prior to initiation of the next HD session, aspirate and discard solution from the catheter. Note: Not intended for systemic administration or for use as a catheter lock flush.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely as taurolidine/heparin is not intended for systemic administration.
There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely as taurolidine/heparin is not intended for systemic administration.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults. Also see Heparin monograph.
1% to 10%:
Gastrointestinal: Nausea (7%), vomiting (6%)
Hematologic & oncologic: Hemorrhage (7%), thrombocytopenia (2%)
Nervous system: Dizziness (6%)
Neuromuscular & skeletal: Musculoskeletal chest pain (3%)
<1%:
Endocrine & metabolic: Hypocalcemia
Gastrointestinal: Dysgeusia
Postmarketing: Nervous system: Paresthesia
Hypersensitivity to taurolidine, heparin, the citrate excipient, pork products, or any component of the formulation; known heparin-induced thrombocytopenia.
Concerns related to adverse effects:
• Heparin-induced thrombocytopenia: Heparin-induced thrombocytopenia (HIT), a serious antibody-mediated reaction resulting from irreversible aggregation of platelets, may occur. Patients who develop HIT may be at risk of developing a new thrombus (heparin-induced thrombocytopenia with thrombosis [HITT]). Discontinue therapy and consider alternatives if platelet count falls below 100,000/mm3, there is a >50% reduction in platelet count from baseline, and/or thrombosis develops while on heparin therapy. Onset of HIT or HITT is usually delayed (5 to 10 days after exposure in heparin-naive individuals) and can occur up to several weeks after discontinuation of heparin. “Rapid onset” HIT can occur within 24 hours of heparin initiation, especially in patients with recent heparin exposure within the previous 100 days. Use with extreme caution (for a limited duration) or avoid use in patients with history of HIT, especially if administered within 100 days of a HIT episode (Dager 2007; Warkentin 2001).
• Hypersensitivity: Hypersensitivity reactions may occur. Discontinue therapy and institute supportive measures if hypersensitivity occurs.
Defencath: FDA approved November 2023; anticipated availability is currently unknown.
Intracatheter: Not intended for systemic administration. Instill into each central venous catheter lumen at the conclusion of each hemodialysis (HD) session. Prior to initiation of the next HD session, aspirate taurolidine and heparin from the catheter and discard; do not use as a catheter lock flush product.
Catheter-related bloodstream infection, prevention: To reduce the incidence of catheter-related bloodstream infections in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC).
Limitations of use: The safety and effectiveness of taurolidine and heparin have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Hydrogen Peroxide: Taurolidine may enhance the adverse/toxic effect of Hydrogen Peroxide. Specifically, concomitant use of taurolidine and hydrogen peroxide may increase the risk of metabolic acidosis. Risk X: Avoid combination
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Povidone-Iodine (Topical): Taurolidine may enhance the adverse/toxic effect of Povidone-Iodine (Topical). Specifically, concomitant use of taurolidine and povidone-iodine may increase the risk of metabolic acidosis. Risk X: Avoid combination
Sodium Hypochlorite: Taurolidine may enhance the adverse/toxic effect of Sodium Hypochlorite. Specifically, concomitant use of taurolidine and sodium hypochlorite may increase the risk of metabolic acidosis. Risk X: Avoid combination
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Vancomycin: May diminish the therapeutic effect of Taurolidine. Risk C: Monitor therapy
Animal reproduction studies have not been conducted.
Not intended for systemic administration; maternal use as a catheter lock solution is not expected to result in fetal exposure.
It is not known if heparin or taurolidine are present in breast milk following use as a catheter lock solution.
Not intended for systemic administration; breastfeeding following use as a catheter lock solution is not expected to provide exposure to an infant via breast milk.
Taurolidine is a thiadiazinane antimicrobial derived from the amino acid taurine. Taurolidine and its metabolites damage microbial cell walls and inhibit adherence of microorganisms to biological surfaces.
Heparin potentiates the action of antithrombin III and thereby inactivates thrombin (as well as other coagulation factors IXa, Xa, XIa, XIIa, and plasmin) and prevents the conversion of fibrinogen to fibrin; heparin also stimulates release of lipoprotein lipase (lipoprotein lipase hydrolyzes triglycerides to glycerol and free fatty acids).
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