From the FDA Drug Label
DEFITELIO was administered to the treatment group at a dose of 6.25 mg/kg infused every 6 hours for a minimum of 21 days DEFITELIO at a dose of 6.25 mg/kg infused every 6 hours
The infusion time for defibrotide is not explicitly stated in the provided drug labels. However, it can be inferred that the dose of 6.25 mg/kg is infused every 6 hours.
From the Research
Defibrotide should be administered as a 2-hour intravenous infusion given every 6 hours (four times daily). The recommended dose is 6.25 mg/kg every 6 hours, with the total daily dose being 25 mg/kg. The medication should be diluted in an appropriate volume of diluent (typically 5% dextrose in water or 0.9% sodium chloride) prior to administration. It's essential to maintain the 2-hour infusion time consistently for all doses to ensure proper drug exposure and efficacy. Defibrotide works by protecting endothelial cells and restoring the thrombo-fibrinolytic balance in vascular endothelium, which is particularly important in conditions like hepatic veno-occlusive disease/sinusoidal obstruction syndrome. Shortening the infusion time may increase the risk of adverse effects such as hypotension, while extending it could potentially reduce efficacy. Treatment typically continues for a minimum of 21 days and should be continued until resolution of symptoms or up to a maximum of 60 days if needed, as supported by the study published in 2021 2.
Some key points to consider when administering defibrotide include:
- The importance of consistent infusion time to ensure proper drug exposure and efficacy
- The potential risks of shortening or extending the infusion time, including increased risk of adverse effects or reduced efficacy
- The need to continue treatment until resolution of symptoms or up to a maximum of 60 days if needed
- The recommended dose and administration schedule, as outlined in the study published in 2021 2
It's also worth noting that defibrotide has been shown to be effective in treating hepatic veno-occlusive disease/sinusoidal obstruction syndrome, with significant improvement in day +100 survival and complete response rate, as demonstrated in the phase 3 trial published in 2016 3. However, the most recent and highest quality study, published in 2023 4, did not show a benefit of defibrotide in the prophylaxis of sinusoidal obstruction syndrome, highlighting the need for careful consideration of the treatment approach in each individual case.