- 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 haematopoietic stem-cell transplantation (HSCT) therapy
- Supplied as ampoules of 80 mg/mL defibrotide
- Store vials at room temperature. Single use only
- Further dilute in 0.9% NaCl or D5W to a concentration of 4 to 20 mg/ml. Mix gently.
- Depending on the type and amount of diluent, the color of the diluted solution may vary from colorless to light yellow.
- Stable 4 hours at room temperature or 24 hours refrigerated
- Does not need to be protected from light
- Solutions Compatible: 0.9% NaCl, D5W
- Additives/Above Cassette Compatible: no information
- Y-site compatible: no information
(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)
|IV Intermittent Infusion||
Standard Concentrations: 4 mg/mL , 20 mg/mL
Infusion Time: 2 hours
|IV Continuous Infusion||NO|
(For neonatal dosages, refer to Neonatal IV Drug Manual.)
- Utilize baseline body weight (prior to the preparative hematopoietic stem cell transplantation regimen or prior to VOD episode) to calculate the defibrotide dose
- Prior to administration, confirm that the patient is not experiencing clinically significant bleeding and is hemodynamically stable on no more than one vasopressor.
- Dose: 25 mg/kg/day divided q6h
- From product monograph: Administer for a minimum of 21 days. If after 21 days signs and symptoms of hepatic VOD have not resolved, continue until resolution of VOD. Adults: Max 60 days.
- Incidence over 10%: hypotension, diarrhea, vomiting, nausea, epistaxis, hemorrhage (any type)
- Incidence over 5%: pulmonary alveolar hemorrhage, gastrointestinal hemorrhage, pneumonia
Rare or frequency not defined: hypersensitivity reaction (rash, urticarial, angioedema), anaphylaxis (case reports) hyperuricemia, intracranial or cerebral hemorrhage, infection/sepsis, hematuria, renal failure, hot flash, thrombophlebitis, fever
- Co-administration of defibrotide with anticoagulants or agents decreasing platelet aggregation is a contraindication (heparin flushes for central line management are permitted)
- For persistent, severe or potentially life-threatening bleeding: Withhold defibrotide; treat underlying cause of bleeding and provide supportive care. Consider reinitiating treatment (at the same dose and volume) when bleeding has resolved and the patient is hemodynamically stable.
- For recurrent significant bleeding: Discontinue permanently (do not resume).
- No dosage adjustments required for renal or hepatic impairment.
- Invasive procedures: Discontinue defibrotide at least 2 hours prior to procedure. May resume treatment post-procedure once any risk of bleeding (related to procedure) is resolved
Drug Monograph: Defitelio® (Defribrotide sodium).Jazz Pharmaceutical Ireland Limited, July 10th 2017 .
Lexicomp Online® , Lexi-Drugs® , Hudson, Ohio: Lexi-Comp, Inc.; 22 November 2017