Defibrotide sodium

What is Defibrotide sodium?

• 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.

What are the uses of this medicine?

• 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).

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• systemic anticoagulant or fibrinolytic therapy
• Known hypersensitivity to Defitelio or to any of its excipients

What drug interactions can this medicine cause?

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

Is this medicine FDA approved?

• It was approved for use in the United States in 2016.

How should this medicine be used?

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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 200 mg/2.5 mL (80 mg/mL) in a single-patient-use vial.

This medicine is available in fallowing brand namesː

• Defitelio

What side effects can this medication cause?

The most common side effects of this medicine include:

• hypotension
• diarrhea
• vomiting
• nausea
• epistaxis

What special precautions should I follow?

• 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.

What to do in case of emergency/overdose?

• There are no known cases of overdose with Defitelio.

Management for overdosage:

• There is no known antidote for Defitelio, and Defitelio is not dialyzable.
• If an overdose occurs, institute general supportive measures.

Can this medicine be used in pregnancy?

• There are no available data on Defitelio use in pregnant women.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active ingredient:

• DEFIBROTIDE SODIUM

Inactive ingredients:

• TRISODIUM CITRATE DIHYDRATE
• WATER
• HYDROCHLORIC ACID
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

Distributed by: Jazz Pharmaceuticals, Inc. Palo Alto

What should I know about storage and disposal of this medication?

• 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)

• Dailymed label info on Defibrotide sodium
• FDA Defibrotide sodium

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