These highlights do not include all the information needed to use DEFITELIO safely and effectively. See full prescribing information for DEFITELIO.
DEFITELIO (defibrotide sodium) injection, for intravenous use
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
DEFITELIO is indicated 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). (1)
DOSAGE AND ADMINISTRATION
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Administer DEFITELIO 6.25 mg/kg every 6 hours given as a 2-hour intravenous infusion. ( 2.1)
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Treat for a minimum of 21 days. If after 21 days signs and symptoms of VOD have not resolved, continue treatment until resolution. ( 2.1)
DOSAGE FORMS AND STRENGTHS
Injection: 200 mg/2.5 mL (80 mg/mL) in a single-patient-use vial. (3)
CONTRAINDICATIONS
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•Concomitant administration with systemic anticoagulant or fibrinolytic therapy. ( 4)
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•Known hypersensitivity to DEFITELIO or to any of its excipients. ( 4)
WARNINGS AND PRECAUTIONS
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•Hemorrhage: Monitor patients for bleeding. Withhold or discontinue DEFITELIO if significant bleeding occurs. ( 2.3, 5.1)
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•Hypersensitivity Reactions: If severe or life threatening allergic reaction occurs, discontinue DEFITELIO, treat according to standard of care, and monitor until signs and symptoms resolve. ( 2.3, 5.2)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥10% and independent of causality) with DEFITELIO treatment were hypotension, diarrhea, vomiting, nausea, and epistaxis. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals, Inc. at 1-800-520-5568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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DEFITELIO may enhance the activity of antithrombotic/fibrinolytic drugs. ( 7)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 3/2016
