Taurolidine-Heparin

Taurolidine-Heparin is a prescription medication indicated to reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adults with kidney failure receiving long-term hemodialysis (HD) through a central venous catheter (CVC).

• Taurolidine-Heparin is available under the following different brand names: Defencath

Common side effects of Taurolidine-Heparin include:

• hemodialysis catheter malfunction
• hemorrhage/bleeding
• nausea
• vomiting
• dizziness
• musculoskeletal chest pain
• thrombocytopenia

Serious side effects of Taurolidine-Heparin include:

• not available

Rare side effects of Taurolidine-Heparin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Catheter lock solution

• 13.5 mg/1,000 units/mL (3-mL, 5-mL single-dose vials)

Catheter-related bloodstream infections

Adult dosage

• NOTE: Use is limited to a specific patient population
• For instillation into CVCs only
• Not intended for systemic administration
• Do NOT use it as a catheter lock flush product
• Use a 3-mL or 5-mL single-dose vial (depending on the volume of catheter lumens) to instill Taurolidine-Heparin into each catheter lumen after completing each HD session
• Before initiating the next HD session, aspirate Taurolidine-Heparin from the catheter and discard

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Taurolidine-Heparin has no noted severe interactions with any other drugs
• Taurolidine-Heparin has no noted serious interactions with any other drugs
• Taurolidine-Heparin has no noted moderate interactions with any other drugs
• Taurolidine-Heparin has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

What Are Warnings and Precautions for Taurolidine-Heparin?

Contraindications

• Known heparin-induced thrombocytopenia (HIT)
• Known hypersensitivity to taurolidine, heparin, citrate excipient, or pork products

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Taurolidine-Heparin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Taurolidine-Heparin?”

Cautions

• HIT reported; if HIT occurs, discontinue and institute appropriate supportive measures
• Drug hypersensitivity reactions may occur; if a hypersensitivity reaction occurs, discontinue and institute appropriate supportive measures

Pregnancy and Lactation

• Not intended for systemic administration
• Maternal use is not expected to result in fetal drug exposure
• No animal reproduction studies have been conducted
• Lactation
  • Not intended for systemic administration
  • Breastfeeding is not expected to result in drug exposure to infants