Active Ingredient: Defibrotide
Defibrotide is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy.
It is indicated in adults and in adolescents, children and infants over 1 month of age.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, 6.25 milligrams defibrotide per kilogram of body weight, once every 6 hours, over the duration of 21 days.
The recommended dose is 6.25 mg/kg body weight every 6 hours (25 mg/kg/day).
There is limited efficacy and safety data on doses above this level and consequently it is not recommended to increase the dose above 25 mg/kg/day.
The treatment should be administered for a minimum of 21 days and continued until the symptoms and signs of severe VOD resolve.
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