Miscellaneous gastrohepatic disorders:

Indications for: DEFITELIO

Treatment of hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation.

Adults and Children:

Confirm patient is hemodynamically stable on ≤1 vasopressor. Give by IV infusion over 2hrs. 6.25mg/kg every 6hrs for at least 21 days; if VOD unresolved after 21 days, continue until resolution or up to max 60 days. Treatment modification: see full labeling.

DEFITELIO Contraindications:

Concomitant systemic anticoagulant or fibrinolytic therapy.

DEFITELIO Warnings/Precautions:

Increased risk of bleeding; monitor. Active bleeding: do not initiate. Discontinue permanently if severe or life-threatening hypersensitivity reaction or recurrent significant bleeding occurs. Withhold if persistent, severe or potentially life-threatening bleeding occurs; consider resuming when bleeding has stopped. Discontinue ≥2hrs prior to an invasive procedure; resume as soon as any procedure-related bleeding risk has resolved. Pregnancy: potential risk of miscarriage. Nursing mothers: not recommended.

DEFITELIO Classification:

Anticoagulant.

DEFITELIO Interactions:

See Contraindications. Discontinue concomitant anticoagulants and fibrinolytics before initiating Defitelio.

Adverse Reactions:

Hypotension, diarrhea, vomiting, nausea, epistaxis; hemorrhage, hypersensitivity reactions.

Generic Drug Availability:

NO

How Supplied:

Single-use vials—10