Defibrotide使用说明

Defibrotide(R) has received marketing authorization from the European Commission for the treatment of severe hepatic VOD in hematopoietic stem cell transplantation (HSCT). A phase 3 randomized controlled trial of defibrination to prevent hepatic VOD in pediatric transplant patients has also been completed. Defibrotide has been generally well tolerated; the most common adverse reactions observed during premarketing use to treat hepatic VOD were bleeding, hypotension, and coagulopathy. 

Instructions for use of Defibrotide: 1. Recommended dose: The recommended dose of Defibrotide for adult and pediatric patients is 6.25 mg/kg given every 6 hours as a 2-hour intravenous infusion. The dose should be based on the patient's baseline weight, which is defined as the patient's weight before the HSCT preparation protocol. Give defibrotide for a minimum of 21 days. If signs and symptoms of hepatic VOD have not resolved after 21 days, continue defibrotide until resolution of VOD or up to a maximum of 60 days. 2. Dosing Instructions: Defibrotide must be diluted prior to infusion; prior to administration of Defibrotide, confirm that the patient has not experienced clinically significant bleeding and is hemodynamically stable to no more than one vasopressor, constant over a 2-hour period. Administer Defibrotide by intravenous infusion; use an infusion set equipped with a 0.2 micron in-line filter to administer a diluted Defibrotide solution. Use 5% Glucose Injection, USP or 0.9% Sodium Chloride Injection, USP immediately before and after administration. Flush intravenous administration lines (peripheral or central). Do not coadminister defibrinoside () with other intravenous drugs at the same time and in the same intravenous line.