When was defibrinoside launched on the market?

Defibrotide 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 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. Defibrotide was administered 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. Do not coadminister defibrotide with other intravenous medications at the same time and in the same intravenous line.

  Concomitant use of defibrotide 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 therapy, and consider delaying initiation of defibrotide administration until the effects of the anticoagulant have lessened.

So when was defibrinoside launched on the market?

Defibrotide 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 is the first drug approved by the U.S. FDA to treat severe hepatic veno-occlusive disease. It is used for adult or pediatric patients with hepatic venous obstruction (VOD) who have undergone blood or bone marrow hematopoietic stem cell transplantation (HSCT) and are accompanied by renal or lung function abnormalities. The drug has also received "orphan drug" designation.