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Important Safety Information Full Prescribing Information
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Product Profile > Phase 3 Study Results

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® [package insert]: Melinta Therapeutics, Inc.; 2019.
  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® [package insert]: Melinta Therapeutics, Inc.; 2019.
  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® [package insert]: Melinta Therapeutics, Inc.; 2019.
  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® [package insert]: Melinta Therapeutics, Inc.; 2019.

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® [package insert]: Melinta Therapeutics, Inc.; 2019.

 INDICATION AND USAGE

ORBACTIV® (oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and -resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORBACTIV® and other antibacterial drugs, ORBACTIV® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

 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 may remain falsely elevated for approximately 120 hours (5 days) after ORBACTIV® administration.

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

Warnings and Precautions

Coagulation test interference: Oritavancin has been shown to artificially prolong aPTT for up to 120 hours and may prolong PT and INR for up to 12 hours, and ACT for up to 24 hours. Oritavancin has also been shown to elevate D-dimer concentrations up to 72 hours. For patients who require aPTT monitoring within 120 hours of oritavancin dosing, consider a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT.

Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of oritavancin products, including ORBACTIV®. Discontinue infusion if signs of acute hypersensitivity occur. Closely monitor patients with known hypersensitivity to glycopeptides.

Infusion Related Reactions: Administer ORBACTIV® over 3 hours to minimize infusion-related reactions. Infusion reactions characterized by chest pain, back pain, chills and tremor have been observed with the use of oritavancin products (e.g. ORBACTIV®), including after the administration of more than one dose of oritavancin during a single course of therapy. Stopping or slowing the infusion may result in cessation of these reactions.

Clostridioides difficile-associated diarrhea: Evaluate patients if diarrhea occurs.

Concomitant warfarin use: Oritavancin has been shown to artificially prolong PT/INR for up to 12 hours. 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 or a prophylactic indication 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.

Please see Full Prescribing Information for ORBACTIV®.

INDICATION AND USAGE

ORBACTIV® (oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and -resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORBACTIV® and other antibacterial drugs, ORBACTIV® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.