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Defibrotide Sodium

Also known as: Defitelio

Route: Intravenous

2 interactions on record

Defibrotide Sodium has 2 known drug interactions based on U.S. FDA drug labeling data. Of these, 2 are contraindicated combinations that should be avoided entirely. Notable interactions include combinations with Alteplase, Heparin. Patients taking Defibrotide Sodium should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Contraindicated: 2

Contraindicated (2)

Defibrotide Sodium + Alteplase— DEFITELIO may enhance the pharmacodynamic activity of alteplase, increasing risk of hemorrhage. Concomitant use is contr…
Defibrotide Sodium + Heparin— DEFITELIO may enhance the pharmacodynamic activity of heparin, increasing risk of hemorrhage. Concomitant use is contrai…

Defibrotide Sodium + Alteplase⛔Contraindicated

DEFITELIO may enhance the pharmacodynamic activity of alteplase, increasing risk of hemorrhage. Concomitant use is contraindicated.

Defibrotide Sodium + Heparin⛔Contraindicated

DEFITELIO may enhance the pharmacodynamic activity of heparin, increasing risk of hemorrhage. Concomitant use is contraindicated.

Contraindications

4 CONTRAINDICATIONS The use of DEFITELIO is contraindicated in the following conditions: • Concomitant administration with systemic anticoagulant or fibrinolytic therapy [see Warnings and Precautions (5.1) ] • Known hypersensitivity to DEFITELIO or to any of its excipients [see Warnings and Precautions (5.2) ] • Concomitant administration with systemic anticoagulant or fibrinolytic therapy. ( 4 ) • Known hypersensitivity to DEFITELIO or to any of its excipients. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary There are no available data on DEFITELIO use in pregnant women. When administered to pregnant rabbits during the period of organogenesis at doses that were comparable to the recommended human dose based on body surface area, defibrotide sodium decreased the number of implantations and viable fetuses. Advise pregnant women of the potential risk of miscarriage. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Data Animal Data Embryo-Fetal toxicity assessment was attempted in rats and rabbits, but was not possible because of high maternal mortality, abortion, and fetal resorption at all doses. Pregnant rats were administered defibrotide sodium from gestational day (GD) 6 to 15 at 0, 240, 1200, and 4800 mg/kg/day by continuous intravenous infusion over 24 hours or at 60, 120, and 240 mg/kg/day by 2-hour infusions 4 times per day. Pregnant rabbits were administered defibrotide sodium at 0, 30, 60, or 120 mg/kg/day from GD 6 to 18 by 2-hour infusions 4 times per day. In another study in pregnant rabbits, 3 separate subgroups of animals were treated with doses of 80 mg/kg/day defibrotide sodium administered by 2-hour infusions 4 times per day for 5 days each in a staggered manner during the organogenesis period. The dose of 80 mg/kg/day is approximately equivalent to the recommended clinical dose on a mg/m 2 basis. Subgroup 1 was dosed from GD 6 to 10, subgroup 2 was dosed from GD 10 to 14, and subgroup 3 was dosed from GD 14 to 18. An increased incidence of unilateral implantation was observed in defibrotide sodium-treated animals. Treatment with defibrotide sodium resulted in a decreased number of implantations and viable fetuses.

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.