Modified diagnostic criteria, grading classification and newly elucidated pathophysiology of hepatic SOS/VOD after haematopoietic cell transplantation. British Journal of Haematology
Author(s): Cairo MS, Cooke KR, Lazarus HM, Chao N.
Published: September 2020
Copyright: © 2020 British Society for Haematology and John Wiley & Sons Ltd
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Financial Disclosure Statement
Mitchell S. Cairo is a consultant and a Speaker Bureau participant and receives research grant funding from Jazz Pharmaceuticals. Kenneth R. Cooke is a consultant and Speaker Bureau participant and has received research grant funding from Jazz Pharmaceuticals. Hillard M. Lazarus is a consultant and Speaker Bureau participant for Jazz Pharmaceuticals. The remaining author declares no conflict of interest.
Detailed information on funding amounts received by the authors of this publication is available at http://www.cms.gov/openpayments.
INDICATION
Defitelio® (defibrotide sodium) 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).
IMPORTANT SAFETY INFORMATION
Contraindications
Defitelio is contraindicated in the following conditions:
- Concomitant administration with systemic anticoagulant or fibrinolytic therapy
- Known hypersensitivity to Defitelio or to any of its excipients
Warnings and Precautions
Hemorrhage
Defitelio may increase the risk of bleeding in patients with VOD after HSCT. Do not initiate Defitelio in patients with active bleeding. Monitor patients on Defitelio for signs of bleeding. If bleeding occurs, withhold or discontinue Defitelio.
Concomitant systemic anticoagulant or fibrinolytic therapy may increase the risk of bleeding and should be discontinued prior to Defitelio treatment. Consider delaying Defitelio administration until the effects of the anticoagulant have abated.
Hypersensitivity Reactions
Hypersensitivity reactions including rash, urticaria, and angioedema have occurred in less than 2% of patients treated with Defitelio. One case of an anaphylactic reaction was reported in a patient who had previously received Defitelio. Monitor patients for hypersensitivity reactions, especially if there is a history of previous exposure. If a severe hypersensitivity reaction occurs, discontinue Defitelio, treat according to the standard of care, and monitor until symptoms resolve.
Most Common Adverse Reactions
The most common adverse reactions (incidence ≥10% and independent of causality) with Defitelio treatment were hypotension, diarrhea, vomiting, nausea, and epistaxis.