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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.

Orbactiv® (oritavancin) for injection order sheet

REFERENCES:

  1. Data on file, The Medicines Company.
  2. ORBACTIV® [package insert], Parsippany, NJ: The Medicines Company; 2016.

Important Safety Information

Contraindications

Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV® administration because the activated partial thromboplastin time (aPTT) test results are expected to remain falsely elevated for approximately 120 hours (5 days) after ORBACTIV® administration.

ORBACTIV® is contraindicated in patients with known hypersensitivity to ORBACTIV®.

Warnings and Precautions

Coagulation test interference: ORBACTIV® has been shown to artificially prolong aPTT for up to 120 hours, and may prolong PT and INR for up to 12 hours, ACT for up to 24 hours, and D-dimer for up to 72 hours.

Hypersensitivity reactions have been reported with the use of antibacterial agents including ORBACTIV®. Discontinue infusion if signs of acute hypersensitivity occur. Monitor closely patients with known hypersensitivity to glycopeptides.

Infusion-related reactions have been reported. Slow the rate or interrupt infusion if infusion reaction develops.

Clostridium difficile-associated colitis: Evaluate patients if diarrhea occurs.

Concomitant warfarin use: Patients should be monitored for bleeding if concomitantly receiving ORBACTIV® and warfarin.

Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis.

Prescribing ORBACTIV® in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.

Adverse Reactions

The most common adverse reactions (≥3%) in patients treated with ORBACTIV® were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.

See Full Prescribing Information

www.orbactiv.com

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