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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 Access and Reimbursement Manager (ARM) in your territory for information about setting up an account

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Call the patient support hotline 1-888-837-4397, Monday through Friday between 8 AM and 8 PM ET to speak with a representative.

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Privacy statement

Thank you!

A Jazz representative will contact you shortly.

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 Statement.

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.

To request medical information about DEFITELIO, visit the Jazz Pharmaceuticals Medical Information Portal.

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MECHANISM OF ACTION

Proposed mechanism of action of Defitelio

See how Defitelio is thought to work within the VOD cascade.

pill bottle icon

Learn more about the progressive cascade of VOD from leading experts

Watch video

Defitelio is thought to act at multiple points across the VOD cascade1

hepatocyte

Hepatocytes

endothelial

Endothelial cells

red blood cell

Red blood cells

white blood cell

White blood cells

platelet activated

Platelets

extracellular matrix

Extracellular matrix

defitelio

Defitelio

Although the mechanism of action has not been fully elucidated, Defitelio has been shown, in vitro, to affect:

showing an endothelial cell

Endothelial cell protection

Defitelio reduced sinusoidal endothelial cell activation by altering the expression of multiple factors (table B).1

B. EFFECTS OF DEFITELIO IN VITRO1-4

Factor
Function
Defitelio action
Tissue plasminogen activator
catalyzes conversion of plasminogen to plasmin
Thrombomodulin
anticoagulant cofactor
von Willebrand factor
stimulates platelet aggregation
Plasminogen activator inhibitor-1
reduces fibrinolysis

Defitelio protected endothelial cells from damage caused by1:

  • Chemotherapy
  • Tumor necrosis factor-α
  • Serum starvation
  • Perfusion
fibrinolysis

Fibrinolysis

Defitelio enhanced the enzymatic activity of plasmin to hydrolyze fibrin clots.1

Defitelio increased endothelial cell–mediated fibrinolysis via modulation of several factors (table B).1

B. EFFECTS OF DEFITELIO IN VITRO1-4

Factor
Function
Defitelio action
Tissue plasminogen activator
catalyzes conversion of plasminogen to plasmin
Thrombomodulin
anticoagulant cofactor
von Willebrand factor
stimulates platelet aggregation
Plasminogen activator inhibitor-1
reduces fibrinolysis

IMPORTANT SAFETY INFORMATION AND INDICATION

Contraindications

Defitelio is contraindicated in the following conditions:

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

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.

Please see full Prescribing Information.

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.

Please see full Prescribing Information.

VOD=veno-occlusive disease.

References: 1. Defitelio [package insert]. Palo Alto, CA: Jazz Pharmaceuticals. 2. Richardson PG, Corbacioglu S, Ho VT, et al. Drug safety evaluation of defibrotide. Expert Opin Drug Saf. 2013;12(1):123-136. 3. Coppell JA, Brown SA, Perry DJ. Veno-occlusive disease: cytokines, genetics, and haemostasis. Blood Rev. 2003;17(2):63-70. 4. Yau JW, Teoh H, Verma S. Endothelial cell control of thrombosis. BMC Cardiovasc Disord. 2015;15:130.