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ORBACTIV® concentration-dependent in vitro activity assessed by time-kill, compared to vancomycin, against a CA-MRSA strain (NRS 384; USA 300)

Orbactiv® (oritavancin) antibacterial activity clinical study data Orbactiv® (oritavancin) antibacterial activity clinical study data

*In vitro activity does not necessarily correlate to clinical efficacy.

REFERENCES:

  1. Data on file.
  2. Arhin FF, et al. Int J Antimicrob Agents. 2013;41:387-398.
  3. Arhin FF, et al. Int J Antimicrob Agents. 2012;39:159-162.
  4. ORBACTIV® (oritavancin) Prescribing Information, Parsippany, NJ: The Medicines Company; 2016.

ORBACTIV® (oritavancin) is highly active in vitro against designated gram-positive bacteria*

MIC90 values for common ABSSSI pathogens

In vitro activity of ORBACTIV® against gram-positive organisms from the United States and Europe (2010-2012)

Orbactiv® (oritavancin) and gram-positive bacteria clinical data
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*In vitro activity does not necessarily correlate to clinical efficacy.

REFERENCES:

  1. Data on file.
  2. ORBACTIV® (oritavancin) Prescribing Information, 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

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