去纤苷何时上市？

When was defibrotide (defiteli sodium) launched on the market? Many patients ask this question. Defiteli (defiteli) was first developed by Gentium Pharmaceuticals in Italy. It was approved for marketing in the European Union in October 2013. It was approved for marketing in the United States by the U.S. Food and Drug Administration (FDA) on March 30, 2016, under the trade name Defitelio. Defibrotide (defiteli) is the first drug approved by the U.S. FDA for the treatment of severe hepatic veno-occlusive disease. It is used for adult or pediatric patients with hepatic venous obstruction (VOD) and abnormal renal or lung function after receiving blood or bone marrow hematopoietic stem cell transplantation (HSCT). The drug has also received "orphan drug" designation.

Defibrotide (defiteli) is an adenosine receptor agonist with multiple effects. The adenosine A1/A2 receptors of endothelial cells are involved in the regulation of endothelial cells and the response of endothelial cells to injury. Defibrotide can act on these receptors to produce a variety of downstream effects. 

The recommended dose of defibrotide (defiteli) 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 (defiteli) for a minimum of 21 days. If signs and symptoms of hepatic VOD do not resolve after 21 days, continue defibrination until resolution of VOD or up to a maximum of 60 days. Do not coadminister defibrotide (defiteli) with other intravenous medications at the same time and in the same intravenous line. 

The concomitant use of defibrotide (defiteli) and a systemic anticoagulant or fibrinolytic therapy (excluding use for routine maintenance or central venous line reopening) may increase the risk of bleeding. Discontinue anticoagulants and fibrinolytics before defibrotide (defiteli) therapy, and consider delaying the initiation of defibrotide (defiteli) administration until the effects of the anticoagulant have lessened.