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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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SIGNS OF RENAL OR PULMONARY DYSFUNCTION

Be alert for the possible signs of renal or pulmonary dysfunction

kindey icon

Renal dysfunction may include1-4

  • Decreased urinary output
  • Elevated creatinine levels (≥1.5 x baseline)
  • Decreased creatinine clearance
  • Decreased glomerular filtration rate
  • Need for dialysis
lung icon

Pulmonary dysfunction may include2,3,5

  • Pulmonary infiltrates
  • Pleural effusion
  • Reduced oxygen saturation
  • Need for supplemental oxygen (nasal cannula)
  • Ventilator dependence

APPROXIMATELY

30% TO 50%

of cases developed multi-organ dysfunction6,a

84%

overall mortality in VOD with multi-organ dysfunction7,b

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View expert discussion regarding the signs of renal or pulmonary dysfunction

Watch video

aBased on a study conducted by Carreras et al that used 2 sets of diagnostic criteria to estimate the incidence of VOD after HSCT.

bBased on 19 studies (235 patients) that specifically determined mortality from severe VOD, as reported within a meta-analysis of 135 studies performed between 1979 and 2007.

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.

HSCT=hematopoietic stem-cell transplantation; MOA=mechanism of action; VOD=veno-occlusive disease.

References: 1. Ng CK, Chan MH, Tai MH, et al. Hepatorenal syndrome. Clin Biochem Rev. 2007;28(1):11-17. 2. Richardson PG, Murakami C, Jin Z, et al. Multi-institutional use of defibrotide in 88 patients after stem cell transplantation with severe veno-occlusive disease and multisystem organ failure: response without significant toxicity in a high-risk population and factors predictive of outcome. Blood. 2002;100(13):4337-4343. 3. Richardson PG, Riches ML, Kernan NA, et al. Phase 3 trial of defibrotide for the treatment of severe veno-occlusive disease and multi-organ failure. Blood. 2016;127(13):1656-1665. 4. Mohty M, Malard F, Abecassis M, et al. Revised diagnosis and severity criteria for sinusoidal obstruction syndrome/veno-occlusive disease in adult patients: a new classification from the European Society for Blood and Marrow Transplantation. Bone Marrow Transplant. 2016;51(7):906-912. 5. McDonald GB, Hinds MS, Fisher LD, et al. Veno-occlusive disease of the liver and multiorgan failure after bone marrow transplantation: a cohort study of 355 patients. Ann Intern Med. 1993;118(4):255-267. 6. Carreras E, Díaz-Beyá M, Rosiñol L, et al. The incidence of veno-occlusive disease following allogeneic hematopoietic stem cell transplantation has diminished and the outcome improved over the last decade. Biol Blood Marrow Transplant. 2011;17(11):1713-1720. 7. 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.