This site is intended for US healthcare professionals only.

First and Only Approved Treatment for Patients with VOD

With renal or pulmonary dysfunction POST HSCT1

VOD=veno-occlusive disease

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).

Get details on how to order Defitelio for your patients

Learn about dosing, administration, storage, and more

Discuss clinical data and reimbursement support with a Jazz representative

Learn more about VOD, also known as SOS

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.

Please see full Prescribing Information.


Reference: 1. Defitelio [package insert]. Palo Alto, CA: Jazz Pharmaceuticals.

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.

Please see full Prescribing Information.

How to order Defitelio® (defibrotide sodium)

McKesson Plasma and Biologics

Phone:
1-877-625-2566

Fax:
1-888-752-7626

Email:
MPBOrders@mckesson.com

Email for all other information requests:
MPB@mckesson.com

  • Orders can be placed Monday through Friday, 9 AM to 7:30 PM ET
    • Overnight delivery is available for orders placed by 7:30 PM ET
    • For emergency orders after hours of service, call 1-877-625-2566 (24/7/365)
  • Verify your institution has a contract with McKesson Plasma and Biologics before ordering; if not, contact McKesson Plasma and Biologics or your Jazz Strategic Account Manager (SAM) in your territory for information about setting up an account

The JumpStart Program at Jazz Pharmaceuticals provides information about coverage and reimbursement. Specialists are available to answer your questions Monday through Friday, 9 AM to 6 PM ET. For additional questions regarding reimbursement, contact your Jazz SAM in your territory.

Contact our JumpStart Specialists at 1-888-837-4397,
Monday through Friday, 9 AM to 6 PM ET.

What is VOD?

Hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome, or SOS, is a potentially life-threatening complication following hematopoietic stem-cell transplant and associated conditioning regimens that affect the endothelial cells within the sinusoids of the liver.1

Reference: 1. Coppell JA, Richardson PG, Soiffer R, et al. Hepatic veno‐occlusive disease following stem cell transplantation: incidence, clinical course, and outcome. Biol Blood Marrow Transplant. 2010;16(2):157‐168.

Request a visit from a Jazz representative

Learn more about clinical information and reimbursement support for Defitelio® (defibrotide sodium) by requesting a visit from a Jazz representative.

Simply fill out the fields below and select submit.

*Indicates required field.
Jazz Pharmaceuticals is committed to helping healthcare professionals provide appropriate care for their patients. Please provide us with the following information so that we or third parties working on our behalf can send you information, services and materials about Defitelio or veno-occlusive disease (VOD). Jazz Pharmaceuticals will not sell or provide your personal information to other parties without your permission. For more information about how Jazz Pharmaceuticals protects your personal information, please click here to view our Privacy Policy. If you prefer not to receive further email communications from Jazz Pharmaceuticals, please click here to unsubscribe.

Contact Us

*Indicates required field.

Jazz Pharmaceuticals respects your interest in keeping your personal information private. The personal information you provide will be used by Jazz Pharmaceuticals to respond to your request. For more information about how Jazz Pharmaceuticals protects your personal information, please click here to view our Privacy Policy.

To contact Jazz Pharmaceuticals Customer Service, please call 1-800-833-3533.

To report suspected adverse reactions, please call Jazz Pharmaceuticals at 1-800-520-5568 or contact the FDA at 1-800-FDA-1088.

Thank you!

Your message was sent successfully. A Jazz representative will contact you shortly.