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).

DOSAGE

Recommended Dosage

The recommended dosage of DEFITELIO for adult and pediatric patients is 6.25 mg/kg every 6 hours given as a 2‑hour intravenous infusion. The dose should be based on patient’s baseline body weight, defined as the patient’s weight prior to the preparative regimen for HSCT.

Administer DEFITELIO for a minimum of 21 days. If after 21 days signs and symptoms of hepatic VOD have not resolved, continue DEFITELIO until resolution of VOD or up to a maximum of 60 days.

ADVERSE REACTIONS

Hemorrhage

Hypersensitivity Reactions

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/2c3db989-d7ad-41ed-9ebf-698dcf6c24ec/spl-doc?hl=Defitelio

Defitelioinformation