AHFS Class:

20:12.10 von Willebrand Factor-related Antithrombotics

Generic Name

• Defibrotide Sodium

Defibrotide sodium is available as an 80-mg/mL concentrate for injection in vials containing 2.5 mL of solution; vials contain no preservative and are intended for single-patient use.³¹⁴⁸ Each mL of solution also contains sodium citrate 10 mg in water for injection.³¹⁴⁸ Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH.³¹⁴⁸

Defibrotide sodium concentrate for injection must be diluted prior to administration.³¹⁴⁸ The appropriate volume of the concentrate should be withdrawn from the vial and transferred to an infusion bag containing dextrose 5% or sodium chloride 0.9%.³¹⁴⁸ The diluted solution for infusion should be gently mixed and should have a final concentration of 4 to 20 mg/mL.³¹⁴⁸

pH

Defibrotide sodium concentrate for injection has a pH ranging from 6.8 to 7.8.³¹⁴⁸

Trade Name(s)

Defitelio

Defibrotide sodium is administered intravenously as an infusion over 2 hours after dilution in dextrose 5% or sodium chloride 0.9%.³¹⁴⁸ The final diluted solution for infusion should be administered through an infusion set containing a 0.2-µm inline filter.³¹⁴⁸ The intravenous infusion line being used to administer defibrotide sodium should be flushed with dextrose 5% or sodium chloride 0.9% immediately prior to and following administration of the drug.³¹⁴⁸

Intact vials of defibrotide sodium should be stored at controlled room temperature.³¹⁴⁸ Defibrotide sodium concentrate for injection is a clear, light yellow to brown solution; the diluted solution for infusion may vary from colorless to light yellow, depending upon the diluent and the final concentration of the drug in the solution.³¹⁴⁸ The diluted solution for infusion should be visually inspected for particulate matter and discoloration prior to administration; only clear solutions without visible particulates should be used.³¹⁴⁸

The manufacturer states that diluted solutions for infusion should be used within 4 hours if stored at room temperature or 24 hours if stored under refrigeration.³¹⁴⁸

Vials are intended for single-patient use only.³¹⁴⁸ The manufacturer states that up to 4 doses of the diluted solution for infusion may be prepared at one time if refrigerated.³¹⁴⁸ Partially used vials should be discarded.³¹⁴⁸

Filtration

Defibrotide solution diluted for infusion should be administered through an infusion set containing a 0.2-µm inline filter.³¹⁴⁸

Solution Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions December 5, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.