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BLOOD AND BLOOD FORMING ORGANS › ANTITHROMBOTIC AGENTS › ANTITHROMBOTIC AGENTS › Other antithrombotic agents
defibrotide
B01AX01
Forms & Strengths
- Intravenous solution: 200 mg/2.5 mL (80 mg/mL) in single-dose vials
Adult Dosing
- Hepatic veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS) with renal or pulmonary dysfunction post-hematopoietic stem cell transplantation: 25 mg/kg/day administered as 6.25 mg/kg every 6 hours as a 2-hour intravenous infusion
- Duration of treatment: Minimum of 21 days; continue until resolution of VOD/SOS or up to 60 days
Pediatric Dosing
- Hepatic VOD/SOS with renal or pulmonary dysfunction post-HSCT (infants, children, and adolescents): 25 mg/kg/day administered as 6.25 mg/kg every 6 hours as a 2-hour intravenous infusion
- Dosing based on baseline body weight prior to treatment course
- Duration of treatment: Minimum of 21 days; continue until resolution of VOD/SOS or up to 60 days
Indications
- 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)
Mechanism of Action
- Acts as an adenosine receptor agonist
- Exerts profibrinolytic, antithrombotic, and anti-inflammatory effects
- Increases tissue factor pathway inhibitor (TFPI), t-PA, and u-PA expression while decreasing von Willebrand factor and plasminogen activator inhibitor-1 (PAI-1)
- Protects endothelial cells from activation and damage
Contraindications
- Concomitant systemic anticoagulant or fibrinolytic therapy
- Known hypersensitivity to defibrotide or its excipients
- Active bleeding
Adverse Reactions
- Hemorrhage (including gastrointestinal, pulmonary, and central nervous system bleeding)
- Hypotension
- Coagulopathy
- Vomiting, nausea, and diarrhea
- Sepsis
- Hypokalemia
Drug Interactions
- Systemic anticoagulants (e.g., heparin, warfarin): Increased risk of hemorrhage; concomitant use is contraindicated
- Fibrinolytic therapy (e.g., alteplase, tissue plasminogen activators): Increased risk of severe bleeding; concomitant use is contraindicated
Curated Content: Needs Vetting Before Put to Clinical Use