Taurolidine; heparin is a catheter lock solution combination of a thiadiazinane antimicrobial and an anticoagulant indicated to reduce the incidence of catheter-related bloodstream infections in adults with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). The safety and effectiveness of taurolidine; heparin have not been established for use in populations other than adults with kidney failure receiving chronic hemodialysis through a CVC. Taurolidine; heparin is not intended for systemic administration or as a catheter lock flush product. In a double-blind, randomized, active-controlled trial, catheter-related bloodstream infections occurred in 2.3% of subjects receiving taurolidine; heparin compared to 8% of subjects receiving heparin as a catheter lock solution [risk reduction 71% (95% CI 38% to 86%), p less than 0.0006]. In general, adverse events to taurolidine; heparin were reported at a similar rate to heparin alone as a catheter lock solution.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Injectable Administration
Other Injectable Administration
Intracatheter Administration
-Taurolidine; heparin is for instillation into central venous catheters (CVCs) only.
-Taurolidine; heparin is not for systemic administration or for use as a cather lock flush product.
-Withdraw a sufficient volume of 13.5 mg/mL taurolidine; 1,000 units/mL heparin catheter lock solution from the vial using a sterile needle and syringe to fill each lumen of the CVC.
-Prior to the start of the next hemodialysis session, aspirate taurolidine; heparin from the CVC and discard.
-Storage: Each single-dose vial is for use with a single patient as a single instillation in the CVC. Discard any unused portion remaining in the vial.
Hemodialysis catheter malfunction was reported in 17% of subjects receiving taurolidine; heparin during clinical trials. Loss of catheter patency, defined as requiring use of a thrombolytic agent (12%), catheter removal (7%), and catheter removal without thrombolytic use (4%), was reported in 16% of subjects receiving taurolidine; heparin.
If a drug hypersensitivity reaction occurs, discontinue taurolidine; heparin and institute appropriate supportive measures.
Bleeding (7%) and thrombocytopenia (2%) were reported in subjects receiving taurolidine; heparin during clinical trials. Adverse bleeding events included hematoma/hemorrhage, intracranial bleeding (cerebral/cerebellar hemorrhage), arteriovenous graft or fistula site hemorrhage, catheter site hematoma/hemorrhage, ocular hemorrhage, GI bleeding, hematuria, hemobilia, hemoptysis, renal hematoma, and uterine or vaginal bleeding. Discontinue taurolidine; heparin and institute appropriate supportive measures if heparin-induced thrombocytopenia (HIT) occurs.
Dizziness was reported in 6% of subjects receiving taurolidine; heparin during clinical trials. Paresthesias have been reported in postmarketing experience with taurolidine; heparin.
Musculoskeletal chest pain, including non-cardiac chest pain (unspecified) and chest discomfort, was reported in 3% of subjects receiving taurolidine; heparin during clinical trials.
Nausea (7%) and vomiting (6%), including procedural nausea and vomiting, were reported in subjects receiving taurolidine; heparin during clinical trials. Dysgeusia was reported in less than 1% of subjects receiving taurolidine; heparin.
Hypocalcemia was reported in less than 1% of subjects receiving taurolidine; heparin during clinical trials.
Taurolidine; heparin is contraindicated in persons with known taurolidine hypersensitivity, heparin hypersensitivity, citrate hypersensitivity, or porcine protein hypersensitivity. If a drug hypersensitivity reaction occurs, discontinue taurolidine; heparin and institute appropriate supportive measures.
Taurolidine; heparin is contraindicated in persons with a known heparin-induced thrombocytopenia (HIT).
Taurolidine; heparin is not intended for systemic administration. It is intended for use as a catheter lock solution; therefore, use during pregnancy is not expected to result in fetal exposure to taurolidine; heparin. No animal reproduction study was conducted with taurolidine; heparin.
Taurolidine; heparin is not intended for systemic administration. It is intended for use as a catheter lock solution; therefore, breast-feeding is not expected to result in exposure of the infant to taurolidine; heparin.
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Candida albicans, Candida glabrata, Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus (MRSA), Staphylococcus aureus (MSSA), Staphylococcus epidermidis
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
For catheter-related bloodstream infection prophylaxis in persons with kidney failure receiving chronic hemodialysis through a central venous catheter:
Intracatheter dosage:
Adults: Instill sufficient volume of 13.5 mg/mL taurolidine; 1,000 units/mL heparin to fill each lumen of the central venous catheter at the end of each hemodialysis session.
Maximum Dosage Limits:
-Adults
Sufficient volume to fill each catheter lumen.
-Geriatric
Sufficient volume to fill each catheter lumen.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Taurolidine; Heparin products.
Taurolidine; heparin is a catheter lock solution combination of a thiadiazinane antimicrobial and an anticoagulant.
-Taurolidine: The antimicrobial effect of taurolidine and its metabolites is non-specific, causing damage to microbial cell walls and inhibiting adherence of microorganisms to biological surfaces. It is bactericidal at 1 to 4 times the MIC.
-Heparin: 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. This inhibits the activated coagulation factors involved in the clotting sequence, particularly Xa and IIa. Small amounts of heparin inhibit factor Xa, and larger amounts inhibit thrombin (factor IIa). Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor. Heparin does not have fibrinolytic activity and will not lyse existing clots.
Taurolidine; heparin is instilled into the lumens of a central venous catheter. No pharmacokinetic studies have been because taurolidine; heparin is not intended for systemic administration.
Affected cytochrome P450 isoenzymes and drug transporters: none