Defibrotide is a drug used to treat hepatic veno-occlusive disease (VOD), and its main component is a thrombolytic enzyme. VOD is a rare and serious liver disease characterized by impaired blood circulation due to narrowing or blockage of the hepatic veins. However, defibrotide has not yet been marketed in China, nor has it been included in the medical insurance list.

Dosage and Administration of Defibrotide (Defitelio)

Recommended Dosage

(1) The recommended dosage of defibrotide for adult and pediatric patients is 6.25 mg/kg every 6 hours, administered by intravenous infusion over 2 hours. The dosage should be based on the patient's baseline weight, which is defined as the patient's weight before the hematopoietic stem cell transplantation (HSCT) conditioning regimen.

(2) Defibrotide should be used for at least 21 days. If the signs and symptoms of hepatic veno-occlusive disease (VOD) do not resolve after 21 days, continue using defibrotide until VOD resolves or for a maximum of 60 days.

Administration Instructions

(1) Defibrotide must be diluted before infusion.

(2) Before using defibrotide, ensure that the patient has no clinically significant bleeding and is hemodynamically stable with the use of no more than one vasopressor.

(3) Administer defibrotide as a continuous intravenous injection over 2 hours.

(4) Infuse the diluted defibrotide solution using an infusion set equipped with a 0.2 μm in-line filter. Flush the intravenous administration line (peripheral or central) immediately before and after administration with 5% Dextrose Injection (USP) or 0.9% Sodium Chloride Injection (USP).

(5) Do not administer defibrotide concomitantly with other intravenous medications in the same vein.

Preparation Instructions

(1) Dilute defibrotide with 5% Dextrose Injection (USP) or 0.9% Sodium Chloride Injection (USP) to a concentration of 4 mg/mL - 20 mg/mL. The diluted solution should be administered within 2 hours.

(2) Vials do not contain antimicrobial preservatives and are for single-patient use only. Partially used vials should be discarded. Diluted defibrotide solutions should be used within 4 hours if stored at room temperature, or within 24 hours if refrigerated. A maximum of four doses of defibrotide solution can be prepared at one time.

(3) Preparation steps:

① Determine the dosage (mg) and number of vials of defibrotide based on the patient's baseline weight (weight before the hematopoietic stem cell transplantation conditioning regimen).

② Calculate the required volume of defibrotide, withdraw that volume from the vial(s), and add it to an infusion bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection to achieve a final concentration of 4 mg/mL - 20 mg/mL.

③ Gently mix the infusion solution.

④ Before administration, visually inspect parenteral drugs for particulate matter and discoloration, whenever solution and container permit. Only clear solutions without visible particles should be used. The color of the diluted solution may range from colorless to pale yellow, depending on the type and amount of diluent used.