Defencath (taurolidine in heparin sodium, porcine)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

*Taurolidine/heparin is for instillation into CVCs only.

*Taurolidine/heparin is not intended for systemic administration.

*Do not use taurolidine/heparin as a catheter lock flush product.

*Withdraw a sufficient volume of taurolidine/heparin catheter lock solution (CLS) 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 the catheter lumens) to instill taurolidine/heparin into each catheter lumen at the conclusion of each hemodialysis session.

*Prior to initiation of the next hemodialysis session, taurolidine/heparin should be aspirated from the catheter and discarded. If taurolidine/heparin cannot beaspirated, continue with standard of care CVC preparation and flush with normal saline. If a catheter malfunction is suspected, appropriate standard of care measures shouldbe instituted.

*Discard any unused portion of taurolidine/heparin remaining in the vial.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known heparin-induced thrombocytopenia (HIT).

*Known hypersensitivity to taurolidine, heparin or the citrate excipient (components of taurolidine/heparin), or pork products.

• Heparin-induced thrombocytopenia

• Thrombocytopenic disorder

• Hemorrhage
• Hyperkalemia
• No disease contraindications

The most frequently reported adverse reactions occurring in greater than or equal to 2% of patients in Trial 1 using taurolidine/heparin as a CLS were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia.

Rare or Very Rare

• Heparin-induced thrombocytopenia
• Hypersensitivity drug reaction

More Frequent

• Chest pain
• Dizziness
• Hemorrhage
• Nausea
• Thrombocytopenic disorder
• Vomiting

Rare or Very Rare

• Dysgeusia
• Hypocalcemia
• Paresthesia

No enhanced messaging available.

The safety and effectiveness of taurolidine/heparin have not been established in pediatric patients. There are no available data on taurolidine/heparin use in pediatric patients.

Taurolidine/heparin is not intended for systemic administration. It is intended for use as a CLS in patients with kidney failure requiring chronic hemodialysis; therefore, maternal use is not expected to result in fetal exposure to the drug. No animal reproduction study was conducted with taurolidine/heparin.

Taurolidine/heparin is not intended for systemic administration. It is intended for use as a CLS in patients with kidney failure requiring chronic hemodialysis; therefore, breastfeeding is not expected to result in exposure of the infant to taurolidine/heparin.

There were 327 patients 65 years of age and older in Trial 1. Of the total number of patients using taurolidine/heparin in this study, 162 (41%) were 65 years of age and older, while 64 (16%) were 75 years of age and older. No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.