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Deepika vegiraju at 07:40, 18 July 2023

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== '''What is Defibrotide?''' ==

* Defibrotide ('''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]].

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== '''What are the uses of this medicine?''' ==

* Defibrotide ('''Defitelio''') 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|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 Agents|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|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|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)

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[[Category:Anticoagulants]]
[[Category:Orphan drugs]]

Defibrotide - Revision history

Prab at 11:08, 20 March 2025

Prab: CSV import

Prab: CSV import

Prab: CSV import

Deepika vegiraju at 07:40, 18 July 2023