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How to order Defitelio® (defibrotide sodium)

McKesson Plasma and Biologics

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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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CLINICAL DATA

Efficacy of Defitelio was evaluated in 689 patients1,2

Studies included a broad range of adult and pediatric patients with VOD with renal or pulmonary dysfunction following HSCT1-3

Study 11,4
Study 21,5
Study 31-3
Study design
Phase 3 
prospective
Phase 2 
prospective
Expanded access 
study
Number of 
patients
102
75
512
VOD associated 
with:

Multi-organ 
dysfunction 
(pulmonary, renal, 
or both)a

Multi-organ 
dysfunctionb

Renal or pulmonary dysfunctionc

Median number 
of days on 
treatment (days) 
(range)
21.5 (1, 58)
19.5 (3, 83)
21.0d (1, 91)
Treatment dose 
of Defitelio
6.25 mg/kg infusion 
every 6 hours
Median age 
(years) (range)
21 (<1, 72)
32 (<1, 61)
14 (<1, 69)
Type of 
transplant, n (%)
Allogeneic
Autologous
90 (88)
12 (12)
67 (89)
8 (11)
450 (88)
61 (12)
Ventilator or 
dialysis 
dependent at 
study entry, n (%)
34 (33)
8 (11)
225 (42)

Defitelio was proven to improve survival at Day +100 consistently across 3 studies1,2

Survival at Day +100 post HSCT with Defitelio across studies in adult and pediatric patients1,2

survival day 1 chart survival day 2 chart

EXPECTED DAY +100 SURVIVAL WITH SUPPORTIVE CARE

21% TO 31%

Based on published reports and analyses of patient-level data for individuals with hepatic VOD with renal or pulmonary dysfunction who received supportive care or interventions other than Defitelio.1

Delays in Defitelio initiation were associated with increased mortality at Day +1002

In an exploratory post hoc analysis from Study 32

  • Analysis of Study 3 indicated that increased mortality at Day +100 was associated with longer delays in Defitelio administration following a diagnosis of VOD with renal or pulmonary dysfunction (confirmed by the Cochran-Armitage trend test; P<0.001)
    • Analysis based on adult and pediatric patients (n=512) with a diagnosis of VOD with renal or pulmonary dysfunction
    • The reason for initiation delay following diagnosis was not assessed in this expanded access study

aA diagnosis of VOD was made using Baltimore criteria (bilirubin ≥2 mg/dL and at least 2 of the following: hepatomegaly, ascites, and weight gain >5% by Day +21 post HSCT).1

bA diagnosis of VOD was made using Baltimore criteria (bilirubin ≥2 mg/dL and at least 2 of the following: ascites, weight gain >5% from baseline, hepatomegaly, or right upper quadrant pain) by Day +35 post HSCT.5

cA diagnosis of VOD was made using Baltimore criteria (bilirubin ≥2 mg/dL and at least 2 of the following: hepatomegaly, ascites, and weight gain >5%) by Day +35 post HSCT or modified Seattle criteria (presentation by Day 20 post HSCT of at least 2 of the following: bilirubin >2 mg/dL, hepatomegaly or right upper quadrant pain, and weight gain >2% of baseline).2,6,7

dDuration of treatment from first dose to last dose is presented because days without treatment were not captured for the expanded access study.

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; VOD=veno-occlusive disease.

References: 1. Defitelio [package insert]. Palo Alto, CA: Jazz Pharmaceuticals. 2. Kernan NA, Grupp S, Smith AR, et al. Final results from a defibrotide treatment-IND study for patients with hepatic veno-occlusive disease/sinusoidal obstruction syndrome. Br J Haematol. 2018;181(6):816-827. 3. Data on file. DEF-2018-022. Palo Alto, CA: Jazz Pharmaceuticals. 4. 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. 5. Richardson PG, Soiffer RJ, Antin JH, et al. Defibrotide for the treatment of severe hepatic veno-occlusive disease and multiorgan failure after stem cell transplantation: a multicenter, randomized, dose-finding trial. Biol Blood Marrow Transplant. 2010;16(7):1005-1017. 6. Jones RJ, Lee KS, Beschorner WE, et al. Venoocclusive disease of the liver following bone marrow transplantation. Transplantation. 1987;44(6):778-783. 7. 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.