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This journal article reprint is being provided as a professional courtesy by Jazz Pharmaceuticals, Inc. This scientific publication contains information that may or may not be contained within the accompanying package insert. Providing this reprint should not be construed as a recommendation for use of any Jazz Pharmaceuticals product for nonapproved uses. Prior to prescribing, please refer to the accompanying Prescribing Information, which includes the approved indication and a discussion of the benefits and risks associated with our product.

The opinions expressed in this reprint do not necessarily reflect those of Jazz Pharmaceuticals. Readers are encouraged to contact the primary authors with questions regarding the content of the reprint. Jazz Pharmaceuticals does not assume responsibility for any injury and/or damage to persons or property out of or related to any use of the information contained in this reprint.

Financial Disclosure Statement

This study was supported by Jazz Pharmaceuticals. Conflict of interest statement: S.C. has served as a consultant to and received honoraria from Gentium/Jazz Pharmaceuticals. N.A.K. received grants from Gentium during the course of the study. N.A.K.'s research was supported by the National Cancer Institute of the National Institutes of Health under award P30 CA008748; the content is solely the responsibility of the author and does not necessarily represent the official views of the National Institutes of Health. A.P. has served on advisory boards and the speakers bureau for and received honoraria from Jazz Pharmaceuticals. R.J.R. and W.T. are employees of and hold stock and/or stock options in Jazz Pharmaceuticals. P.G.R. has served on advisory committees and received honoraria from Jazz Pharmaceuticals.

Detailed information on funding amounts received by the authors of this publication is available at


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).



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


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.

Please see full Prescribing Information.

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