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Single dose ORBACTIV® (oritavancin) was studied in two large, identically-designed Phase 3 trials1-3

Randomized double-blind trial design with 60-day safety follow-up

Orbactiv® (oritavancin) clinical study design
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*Dose modifications could be made based upon trough levels


REFERENCES:

  1. ORBACTIV® (oritavancin) Prescribing Information, Parsippany, NJ: The Medicines Company; 2016.
  2. Corey GR et al. N Engl J Med. 2014;370:2180-2190.
  3. Corey GR et al. CID. 2014;60(2)254-262.

Baseline patient characteristics were consistent between treatment groups across SOLO trials*

Orbactiv® (oritavancin) SOLO clinical trial data
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*mITT population


REFERENCES:

  1. Corey GR et al. N Engl J Med. 2014;370:2180-2190.
  2. Corey GR et al. CID. 2014;60(2)254-262.
  3. Data on file.

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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