defiteli上市了吗？

Is it on the market? In October 2013, defiteli (Defibroside) was approved for marketing in the EU, and its Chinese name is Defiteli. After Gentium Pharmaceuticals was acquired by American Jazz Pharmaceuticals, defiteli was approved by the U.S. Food and Drug Administration (FDA) for marketing in the United States on March 30, 2016. Defiteli (Defibrinoside) is not currently on the market in my country.

Defiteli (defibrotide) is the first drug approved by the FDA for the treatment of severe hepatic venular occlusion, a rare and fatal liver disease. The approval was based on a Phase 2 trial of 75 patients, a Phase 3 trial of 102 patients, and an expansion trial of an additional 351 patients. All patients in the trial were diagnosed with hepatic veno-occlusive disease and associated renal or pulmonary dysfunction after HSCT (hematopoietic stem cell transplantation). In the Phase 2 trial, 44% of patients survived 100 days after transplantation, compared with 38% in the Phase 3 trial and 45% in the expanded trial, and the FDA noted in a report that the expected 100-day survival rate for patients with severe hepatic veno-occlusive disease without defiteli treatment was 21%-31%.

Since it is not yet on the market in our country, many patients who buy this medicine do not know how to use it. The medical companion will give you a brief introduction below.

(Defibrotide) The recommended dose for adult and pediatric patients is 6.25 mg/kg given every 6 hours as a 2-hour intravenous infusion. Concomitant use of 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 defiteli therapy, and consider delaying initiation of defiteli administration until the effects of the anticoagulant have lessened.