DEFIBROTIDE SODIUM

Electrolyte / Mineral

Brand names: DEFITELIO

Intravenous

Mechanism of Action

12.1 Mechanism of Action 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.

Indications

1 INDICATIONS AND USAGE 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). ( 1 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Hemorrhage: Monitor patients for bleeding
1 Hemorrhage DEFITELIO increased the activity of fibrinolytic enzymes in vitro, and it may increase the risk of bleeding in patients with VOD after hematopoietic stem-cell transplantation (HSCT)
Concomitant use of DEFITELIO and a systemic anticoagulant or fibrinolytic therapy (not including use for routine maintenance or reopening of central venous lines) may increase the risk of bleeding

Known Side Effects

1 documented side effects by frequency

Low Blood Pressure

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous