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Single dose ORBACTIV® (oritavancin) was effective at achieving early clinical response at 48-72 hours1-3

Primary endpoint: Early clinical response* rates at 48-72 hours

Orbactiv® (oritavancin) clinical study primary endpoint clinical response
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* Early clinical response defined as a composite of the cessation of spread or reduction in size of baseline lesion, absence of fever, and no rescue antibacterial drug at 48-72 hours.

† mITT population: all randomized patients who received any study drug.

‡ 95% confidence interval (CI) based on the normal approximation to binomial distribution.

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.

Single dose ORBACTIV® (oritavancin) was effective at achieving ≥20% lesion size reduction at 48-72 hours1-3

Secondary endpoint: ≥20% lesion size reduction* rates at 48-72 hours

Orbactiv® (oritavancin) clinical study secondary endpoint lesion size
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* Patients achieving a 20% or greater reduction in lesion area from baseline at 48-72 hours after initiation of therapy.

† mITT population: all randomized patients who received any study drug.

‡ 95% CI based on the normal approximation to binomial distribution.

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.

Single dose ORBACTIV® (oritavancin) was effective at achieving clinical success at day 14-241-3

Secondary endpoint:Clinical success* rates at day 14-24

Orbactiv® (oritavancin) clinical study secondary endpoint clinical results
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* Investigator-assessed clinical success at day 14–24, defined as complete or nearly complete resolution of baseline signs and symptoms related to primary ABSSSI site such that no further treatment with antibacterial drugs was needed.

† mITT population: all randomized patients who received any study drug.

‡ 95% CI based on the normal approximation to binomial distribution.

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.

Demonstrated consistent effect against designated gram-positive pathogens1

Orbactiv® (oritavancin) clinical effect
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* Microbiological intent-to-treat population.

† Baseline bacteremia in the ORBACTIV® arm with relevant microorganisms causing acute bacterial skin and skin structure infections (ABSSSI) included 4 subjects with MSSA and 7 subjects with MRSA. Eight of these 11 subjects were responders at 48-72 hours after initiation of therapy.

‡ Hemolytic streptococci group includes S. pyogenes, S. agalactiae, and S. dysgalactiae.

REFERENCES:

  1. ORBACTIV® (oritavancin) Prescribing Information, Parsippany, NJ: The Medicines Company; 2016.

Single dose ORBACTIV® (oritavancin) demonstrated consistency across endpoints measured in patients with confirmed MRSA1

Response rates for patients with confirmed MRSA in pooled SOLO trials

Orbactiv® (oritavancin) clinical response
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* Early clinical response defined as a composite of the cessation of spread or reductions in size of baseline lesion, absence of fever, and no rescue antibacterial drug at 48-72 hours.

† Patients achieving a 20% greater reduction on lesion area from baseline at 48-72 hours.

‡ Investigator-assessed clinical success at day 14–24, defined as complete or nearly complete resolution of baseline signs and symptoms related to primary ABSSSI site such that no further treatment with antibacterial drugs was needed.

REFERENCES:

  1. ORBACTIV® (oritavancin) Prescribing Information, The Medicines Company, Parsippany, NJ, Jan. 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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