肝小静脉闭塞病用药去纤苷（去纤维钠）说明书

Hepatic veno-occlusive disease medication (Defibrotide Sodium) instructions

[Drug Name] Defibrotide, Defitelio, defiteli, defibrotide, defibrotide sodium

[Indications for defibrotide] It is used for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), and renal or pulmonary dysfunction after hematopoietic stem cell transplantation (HSCT).

[Defibrinoside usage and dosage]

The recommended dose for adult and pediatric patients is 6.25 mg/kg given as a 2-hour intravenous infusion every 6 hours. 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.

Defibrotide must be diluted prior to infusion.

Prior to administration of defibrotide, 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. 

[Side effects of defibrotide] The most common side effects (incidence ≥10% and independent causal relationship) are hypotension, diarrhea, vomiting, nausea and epistaxis.

[Notes on defibrination]

⑴ Bleeding: Monitor the patient for bleeding. If significant bleeding occurs, withhold or discontinue defibrotide.

⑵Hypersensitivity reaction: If severe or life-threatening allergic reaction occurs, discontinue, treat according to standard medical care, and monitor until signs and symptoms resolve.

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