taurolidine/heparin

Therapeutic Classification: anti-infectives, anticoagulants

Pharmacologic Classification: antithrombotics

Indications ⬆ ⬇

REMS

To reduce the incidence of catheter-related bloodstream infections in patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter.

Action ⬆ ⬇

Taurolidine: Causes damage to microbial cell walls and inhibits adherence of microorganisms to biological surfaces; Heparin: Potentiates the inhibitory effect of antithrombin on factor Xa and thrombin.

Therapeutic effects:

Reduction in incidence of catheter-related bloodstream infections.

Pharmacokinetics ⬆ ⬇

Taurolidine

Absorption: Intracatheter administration allows for local action; not systemically absorbed.

Distribution: Not systemically absorbed.

Metabolism/Excretion: Not systemically absorbed.

Half-Life: Unknown.

Heparin

Absorption: Intracatheter administration allows for local action; not systemically absorbed.

Distribution: Not systemically absorbed.

Metabolism/Excretion: Not systemically absorbed.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
Intracatheter	Immediate	Unknown	Unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Known heparin-induced thrombocytopenia;
Known hypersensitivity to taurolidine, heparin, the citrate excipient, or pork products.

Use Cautiously in:

Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

GI: nausea, vomiting

Hemat: BLEEDING, HEPARIN-INDUCED THROMBOCYTOPENIA

MS: musculoskeletal chest pain

Neuro: dizziness

Misc: HD catheter malfunction, loss of catheter patency, hypersensitivity reactions

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

Not intended for systemic administration or for use as a catheter lock flush.

Intracatheter(Adults ): Instill a sufficient volume of catheter lock solution (containing heparin 1000 units/mL and taurolidine 13.5 mg/mL) into each HD catheter lumen at the conclusion of each HD session; prior to initiation of the next HD session, aspirate and discard solution from the catheter.

Availability ⬆ ⬇

Catheter lock solution: taurolidine 13.5 mg/heparin 1000 units per mL

Assessment ⬆ ⬇

Monitor for signs and symptoms of active bleeding (hemoptysis, hematuria, bleeding from the gums, bruises without a cause, hematomas, or prolonged bleeding).
Assess for hypersensitivity reactions (rash, pruritus, anaphylaxis). If hypersensitivity reaction occurs, discontinue taurolidine/heparin and initiate appropriate supportive measures (epinephrine).
Assess catheter site for infection (fever, swelling, warmth, purulent drainage). Confirm dressing of central line is clean, dry, and intact.

Lab Test Considerations:

Obtain baseline platelet count and monitor every 2–3 days during the first 14 days of treatment and during therapy as clinically indicated. May cause heparin-induced thrombocytopenia. If platelet count <100,000/mm³, or there is a >50% ↓ from baseline, or a thrombosis develops, discontinue taurolidine/heparin and consider alternative therapy.
Obtain and monitor PT/INR and aPTT for coagulation status, if indicated.

Implementation ⬆ ⬇

Intracatheter: Withdraw appropriate volume from the vial using a sterile needle and syringe to fill the catheter lumens. Use 3-mL or 5-mL single-dose vial (depending on the volume of catheter lumens). Administer into each central venous catheter lumen at the end of each HD session. Before start of the next HD session, aspirate taurolidine/heparin from the catheter and discard.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications, especially aspirin and NSAIDs.
Advise patient to notify health care professional if signs and symptoms of infection or bleeding occur.
Advise patient of hypersensitivity reactions and to seek immediate medical attention if reactions occur.
Educate patient on appropriate hand hygiene and maintaining proper catheter site hygiene.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Reduction in incidence of catheter-related bloodstream infections.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

72990- CorMedix Inc.
- 72990-103- DEFENCATH
  - 72990-103-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (72990-103-10) / 3 mL in 1 VIAL, SINGLE-DOSE (72990-103-03)

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Pronunciation ⬇

Classifications ⬆ ⬇