Defibrotide Chinese version instructions

Defibrotide Chinese version instructions

【Drug name】Defibrinoside

【Product name】Defitelio

[Other names] Defibrotide, defibrotide, defibrotide

[Specifications] Injection: 200 mg/2.5 mL (80 mg/mL) in a single-patient-use vial.

【Indications】

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).

[Dosage and Administration]

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.

Give 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 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.

【Taboo】

Concomitant administration with systemic anticoagulants or fibrinolytic therapy. Known hypersensitivity to Defibrotide or to any of the excipients.

【Warnings and Precautions】

Bleeding: Monitor patients for bleeding. If significant bleeding occurs, withhold or discontinue Defibrotide.

Hypersensitivity Reaction: If a serious or life-threatening allergic reaction occurs, discontinue defibrotide, treat with standard medical care, and monitor until signs and symptoms resolve.

【Adverse reactions】

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

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