ORBACTIV® (oritavancin) has demonstrated no drug interaction with warfarin in a recent pharmacokinetic drug-drug interaction study: Label Update
ORBACTIV® (oritavancin) may be considered for appropriate acute bacterial skin and skin structure infection (ABSSSI) patients who are also receiving warfarin.
Data from a recent pharmacokinetic drug-drug interaction study demonstrated no drug interaction between ORBACTIV® and warfarin.1
ORBACTIV® has been shown to artificially prolong PT/INR for up to 12 hours after administration. Patients should be monitored for bleeding if concomitantly receiving ORBACTIV® and warfarin.2
Clinical Study Overview
A Phase 1, open-label, drug-drug interaction study in 36 healthy volunteers was conducted to examine the magnitude and duration of effects of a single 1200 mg IV infusion of ORBACTIV® on warfarin plasma pharmacokinetics (PK) and assess the drug-drug interaction potential.1,2
This study demonstrated no effect of ORBACTIV® on warfarin PK, specifically maximum concentration (Cmax) or area under the curve (AUC) , following administration of a single dose of warfarin 25 mg given alone, or administered at the start, 24, or 72 hours after a single 1200 mg ORBACTIV® dose.1,2
To download the Warfarin DDI Study Overview, please click the
PDF link below.
- Data on file, The Medicines Company.
- ORBACTIV® [package insert], Parsippany, NJ: The Medicines Company; 2016.