Defibrinoside Detailed Instructions

Defibrinoside detailed instructions

【Drug name】Defibrinoside

[English name] Defitelio (defibrotide)

[Other names]Defibrotide sodium, defibrinoside

[Indications and uses of defibrate sodium/defitelio]

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).

[Defiberin sodium/Defitelio (Defitelio) 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.

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.

[Defiberin/Defitelio Warnings and Precautions]

Bleeding: Defibrinoside increases plasmin activity in vitro, and sputum may increase the risk of bleeding after hematopoietic stem cell transplantation (HSCT) in patients with VOD. Do not initiate defibrotide in patients with active bleeding. Monitor patients for signs of bleeding. If bleeding occurs in a patient taking DEFITELIO, discontinue defibrotide, treat the cause, and provide supportive care until bleeding has stopped.

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.

Hypersensitivity reaction:

Hypersensitivity reactions have occurred in less than 2% of patients treated with defibrotide. These reactions include rash, urticaria, and angioedema. One case of allergic reaction was reported in a patient who had previously received defibrotide. Monitor patients for hypersensitivity reactions. Especially if there is a history of previous exposure. If a severe hypersensitivity reaction occurs, discontinue defibrotide, treat with standard medical care, and monitor until symptoms resolve.