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Defitelio Generic Name & Formulations
Legal Class
Rx
General Description
Defibrotide sodium 200mg/2.5mL; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Anticoagulant.
How Supplied
Single-use vials—10
Manufacturer
Generic Availability
NO
Defitelio Indications
Indications
Treatment of hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation.
Defitelio Dosage and Administration
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.
Defitelio Contraindications
Contraindications
Concomitant systemic anticoagulant or fibrinolytic therapy.
Defitelio Boxed Warnings
Not Applicable
Defitelio Warnings/Precautions
Warnings/Precautions
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.
Defitelio Pharmacokinetics
See Literature
Defitelio Interactions
Interactions
See Contraindications. Discontinue concomitant anticoagulants and fibrinolytics before initiating Defitelio.
Defitelio Adverse Reactions
Adverse Reactions
Hypotension, diarrhea, vomiting, nausea, epistaxis; hemorrhage, hypersensitivity reactions.
Defitelio Clinical Trials
See Literature
Defitelio Note
Not Applicable
Defitelio Patient Counseling
See Literature
