Defibrotide sodium

What is Defibrotide sodium?[edit | edit source]

Defibrotide sodium (Defitelio) is an oligonucleotide mixture with profibrinolytic properties used to treat hepatic veno-occlusive disease (a condition in which small veins in the liver are blocked) in patients who have kidney or lung problems after a stem cell transplant.

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

The mechanism of action of defibrotide sodium has not been fully elucidated.
In vitro, defibrotide sodium enhances the enzymatic activity of plasmin to hydrolyze fibrin clots.
In vitro, defibrotide sodium increased tissue plasminogen activator (t-PA) and thrombomodulin expression, and decreased von Willebrand factor (vWF) and plasminogen activator inhibitor‑1 (PAI-1) expression, thereby reducing EC activation and increasing EC‑mediated fibrinolysis.
Defibrotide sodium protected ECs from damage caused by chemotherapy, tumor necrosis factor-α (TNF-α), serum starvation, and perfusion.

This medicine cannot be used in patients with:

Concomitant use of Defitelio with antithrombotic or fibrinolytic drugs is contraindicated because of an increased risk of hemorrhage.

Recommended Dosage:

The recommended dosage of Defitelio for adult and pediatric patients is 6.25 mg/kg every 6 hours given as a 2‑hour intravenous infusion.
Administer Defitelio for a minimum of 21 days.
If after 21 days signs and symptoms of hepatic VOD have not resolved, continue Defitelio until resolution of VOD or up to a maximum of 60 days.

Administration

Defitelio must be diluted prior to infusion.
Prior to administration of Defitelio, confirm that the patient is not experiencing clinically significant bleeding and is hemodynamically stable on no more than one vasopressor.
Administer Defitelio by constant intravenous infusion over a 2-hour period.
Administer the diluted Defitelio solution using an infusion set equipped with a 0.2 micron in-line filter.
Flush the intravenous administration line (peripheral or central) with 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP immediately before and after administration.
Do not co‑administer Defitelio and other intravenous drugs concurrently within the same intravenous line.

This medicine is available in fallowing doasage form:

This medicine is available in fallowing brand namesː

The most common side effects of this medicine include:

Defitelio may increase the risk of bleeding in patients with VOD after hematopoietic stem-cell transplantation (HSCT). Monitor patients for bleeding. Withhold or discontinue Defitelio if significant bleeding occurs.
Hypersensitivity reactions have occurred in less than 2% of patients treated with Defitelio. These reactions include rash, urticaria and angioedema.
If severe or life threatening allergic reaction occurs, discontinue Defitelio, treat according to standard of care, and monitor until signs and symptoms resolve.

Management for overdosage:

The safety and effectiveness of Defitelio have been established in pediatric patients.

Active ingredient:

Inactive ingredients:

Distributed by: Jazz Pharmaceuticals, Inc. Palo Alto

Store Defitelio (defibrotide sodium) injection at 20°C-25°C (68°F-77°F); excursions permitted between 15°C to 30°C (59°F to 86°F)

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