Parenteral Manual

Defibrotide (NON-FORMULARY)

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Antithrombotic, Thrombolytic Agent
Original Date: 
August 2006
Revised Date: 
November 2017
  • 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
Reconstitution and Stability: 
  • 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 Direct NO
IV Intermittent Infusion


Standard Concentrations: 4  mg/mL , 20 mg/mL

Infusion Time: 2 hours
Use 0.2 micron in-line filter

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.



Potential hazards of parenteral administration: 
  • 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

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