Generic Name and Formulations:
Defibrotide sodium 200mg/2.5mL; soln for IV infusion after dilution; preservative-free.
Jazz Pharmaceuticals plc
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.
Hypotension, diarrhea, vomiting, nausea, epistaxis; hemorrhage, hypersensitivity reactions.