Drug Detail:Defibrotide (Defibrotide [ de-fye-broe-tide ])
Drug Class: Miscellaneous coagulation modifiers
Usual Adult Dose for Hepatic Veno-Occlusive Disease
6.25 mg/kg IV every 6 hours given as a constant 2-hour infusion
Duration of therapy: Minimum of 21 days; if signs and symptoms of hepatic veno-occlusive disease (VOD) remain after 21 days, continue this drug until resolution of VOD or up to a maximum of 60 days.
Comments: Baseline body weight prior to the preparative regimen for hematopoietic stem-cell transplantation (HSCT) should be used to calculate the dose.
Use: Treatment of patients with hepatic VOD, also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following HSCT.
Usual Pediatric Dose for Hepatic Veno-Occlusive Disease
1 Month or Older:
6.25 mg/kg IV every 6 hours given as a constant 2-hour infusion
Duration of therapy: Minimum of 21 days; if signs and symptoms of hepatic veno-occlusive disease (VOD) remain after 21 days, continue this drug until resolution of VOD or up to a maximum of 60 days.
Comments: Baseline body weight prior to the preparative regimen for hematopoietic stem-cell transplantation (HSCT) should be used to calculate the dose.
Use: Treatment of patients with hepatic VOD, also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following HSCT.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
TREATMENT MODIFICATIONS FOR TOXICITY OR INVASIVE PROCEDURES:
Severe or Life-Threatening Hypersensitivity Reaction (Anaphylaxis): Discontinue this drug permanently; do not resume treatment.
Persistent, Severe, or Potentially Life-Threatening Bleeding: Withhold this drug; treat the underlying cause and provide supportive care as indicated; consider resuming treatment at the same dose and infusion volume when bleeding stops and the patient is hemodynamically stable.
Recurrent Significant Bleeding: Discontinue this drug permanently; do not resume treatment.
Invasive Procedures: Discontinue this drug at least 2 hours prior to an invasive procedure; resume treatment after the procedure as soon as any procedure-related risk of bleeding is resolved.
Precautions
Safety and efficacy have not been established in patients younger than 1 month.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Use an infusion set equipped with a 0.2 micron in-line filter.
- Flush the IV line (peripheral or central) with 5% dextrose injection or 0.9% sodium chloride injection immediately before and after administration.
Storage requirements: After dilution, administer this drug within 4 hours if stored at room temperature or within 24 hours if stored under refrigeration.
Reconstitution/preparation techniques: The manufacturer product information should be consulted.
IV compatibility: Do not administer with other drugs in the same IV line.
General: There is no known antidote for this drug.
Monitoring:
- Hematologic: Signs of bleeding
- Immunologic: Hypersensitivity reactions
Patient advice:
- Instruct patients to immediately report any signs or symptoms suggestive of hemorrhage (unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision).
- Describe the symptoms of allergic reactions, including anaphylaxis, and instruct patients to seek immediate medical attention if they experience such symptoms.
