去纤苷（defiteli）中文版说明书

[Drug Name] Defibrinoside (Defibricide Sodium, defiteli)

[English name] Defitelio, defibrate, defiteli sodium, defiteli

[Other names]Defibrotide sodium, defibrinoside

[Introduction]: Defibrotide (defiteli) was first developed by Gentium Pharmaceuticals in Italy and was approved for marketing in the EU in October 2013. After Gentium Pharmaceuticals was acquired by Jazz Pharmaceuticals of the United States, defiteli (defiteli) was approved by the US Food and Drug Administration (FDA) to be launched in the United States on March 30, 2016, under the trade name Defitelio.

[Indications and uses]

Defibrotide (defiteli) is indicated for the treatment of adults and children with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), and renal or pulmonary dysfunction after hematopoietic stem cell transplantation (HSCT).

[Dosage and Administration]

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 have not resolved after 21 days, continue defibrotide until resolution of VOD or up to a maximum of 60 days.

Defibrotide (defiteli) must be diluted before infusion.

Prior to administration of defiteli, confirm that the patient is not experiencing clinically significant bleeding and is hemodynamically stable on no more than one vasopressor.

Defiteli is given by constant intravenous infusion over a 2-hour period.

Administer 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) with 5% Dextrose Injection, USP, or 0.9% Sodium Chloride Injection, USP, before and immediately after administration.

Do not coadminister defibrotide (defiteli) with other intravenous medications at the same time and in the same intravenous line.

【Adverse reactions】

The most common adverse reactions (incidence ≥10% and independent causal relationship) with treatment with defiteli are hypotension, diarrhea, vomiting, nausea, and epistaxis.

[Drug Interactions] Defibrinoside (defiteli) may enhance the activity of antithrombotic/fibrinolytic drugs.