去纤苷（去纤维钠）说明书

[Drug Name] Defibrinoside (Defibricide Sodium)

[English name] Defitelio (defibrotide)

[Other names]Defibrotide sodium, defibrinoside

[Indications and uses of defibrotide (sodium defibrination)]

Defibrotide 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).

[Defibrotide (Defibrotide Sodium) Dosage and Administration]

The recommended dose of defibrotide (Defibrotide Sodium) 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 (sodium 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.

Defibrotide (Defibrotide Sodium) must be diluted before infusion.

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

Defibrotide was administered 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 with other intravenous medications at the same time and in the same intravenous line.

[Adverse reactions of defibrotide (defibrotide sodium)]

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

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