Defibrotide is a prescription medicine 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). MedsAcross supplies Defibrotide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
DEFITELIO 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).
Source: US FDA prescribing information
The mechanism of action of defibrotide sodium has not been fully elucidated. In vitro, defibrotide sodium enhances the enzymatic activity of plasmin to hydrolyze fibrin clots. Studies evaluating the pharmacological effects of defibrotide sodium on endothelial cells (ECs) were conducted primarily in the human microvascular endothelial cell line. In vitro, defibrotide sodium increased tissue plasminogen activator (t-PA) and thrombomodulin expression, and decreased von Willebrand factor (vWF) and plasminogen activator inhibitor‑1 (PAI-1) expression, thereby reducing EC activation and increasing EC‑mediated fibrinolysis. Defibrotide sodium protected ECs from damage caused by chemotherapy, tumor necrosis factor-α (TNF-α), serum starvation, and perfusion.
Source: US FDA prescribing information
• Administer DEFITELIO 6.25 mg/kg every 6 hours given as a 2-hour intravenous infusion. • Treat for a minimum of 21 days. If after 21 days signs and symptoms of VOD have not resolved, continue treatment until resolution.
Source: US FDA prescribing information
The use of 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 • Concomitant administration with systemic anticoagulant or fibrinolytic therapy. • Known hypersensitivity to DEFITELIO or to any of its excipients.
Source: US FDA prescribing information
• Hemorrhage: Monitor patients for bleeding. Withhold or discontinue DEFITELIO if significant bleeding occurs. • Hypersensitivity Reactions: If severe or life threatening allergic reaction occurs, discontinue DEFITELIO, treat according to standard of care, and monitor until signs and symptoms resolve.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hemorrhage • Hypersensitivity Reactions The most common adverse reactions (incidence ≥10% and independent of causality) with DEFITELIO treatment were hypotension, diarrhea, vomiting, nausea, and epistaxis.
Source: US FDA prescribing information
Antithrombotic Agents DEFITELIO may enhance the pharmacodynamic activity of antithrombotic/fibrinolytic drugs such as heparin or alteplase. Concomitant use of DEFITELIO with antithrombotic or fibrinolytic drugs is contraindicated because of an increased risk of hemorrhage. • DEFITELIO may enhance the activity of antithrombotic/fibrinolytic drugs.
Source: US FDA prescribing information
Store DEFITELIO (defibrotide sodium) injection at 20°C-25°C (68°F-77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Defibrotide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Defitelio 200 mg/2.5 mL injectionIntravenous | Jazz Pharmaceuticals | US FDA | Available on request |
| Defitelio 80 mg/mL injectionIntravenous | Jazz Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Defibrotide and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Defibrotide, including Defitelio.
Yes. The US FDA first approved Defibrotide on 30 March 2016, according to Drugs@FDA.
Yes. Defibrotide has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Defibrotide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Defibrotide is classified under ATC code B01AX01 (Defibrotide).
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