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Drug Name:


Generic Name and Formulations:
Defibrotide sodium 200mg/2.5mL; soln for IV infusion after dilution; preservative-free.

Jazz Pharmaceuticals plc

Therapeutic Use:

Indications for DEFITELIO:

Treatment of hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation.

Adults and Children:

Confirm patient is hemodynamically stable on ≤1 vasopressor. Give by IV infusion over 2hrs. 6.25mg/kg every 6hrs for at least 21 days; if VOD unresolved after 21 days, continue until resolution or up to max 60 days. Treatment modification: see full labeling.


Concomitant systemic anticoagulant or fibrinolytic therapy.


Increased risk of bleeding; monitor. Active bleeding: do not initiate. Discontinue permanently if severe or life-threatening hypersensitivity reaction or recurrent significant bleeding occurs. Withhold if persistent, severe or potentially life-threatening bleeding occurs; consider resuming when bleeding has stopped. Discontinue ≥2hrs prior to an invasive procedure; resume as soon as any procedure-related bleeding risk has resolved. Pregnancy: potential risk of miscarriage. Nursing mothers: not recommended.


See Contraindications. Discontinue concomitant anticoagulants and fibrinolytics before initiating Defitelio.

Pharmacological Class:


Adverse Reactions:

Hypotension, diarrhea, vomiting, nausea, epistaxis; hemorrhage, hypersensitivity reactions.

Generic Availability:


How Supplied:

Single-use vials—10

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