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In the SOLO trials, the safety of a 1200 mg single dose of ORBACTIV® (oritavancin) was evaluated in 976 patients1

Incidence of selected adverse reactions occuring in ≥1.5% of patients receiving ORBACTIV® in the pooled SOLO trials

Orbactiv® (oritavancin) clinical adverse reactions data
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Safety population N=1959; all patients who received the assigned study drug.

The most commonly reported serious adverse reaction was cellulitis in both treatment groups (ORBACTIV®, 1.1%; vancomycin, 1.2%).

REFERENCES:

  1. ORBACTIV® [package insert], Lincolnshire, IL: Melinta Therapeutics, Inc.; 2018.

INDICATION

ORBACTIV® (oritavancin) is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) 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).

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, and ACT for up to 24 hours. ORBACTIV has also been shown to elevate D-dimer concentrations 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: Administer ORBACTIV® over 3 hours to minimize infusion-related reactions. Stopping or slowing the infusion may result in cessation of these reactions.

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

Concomitant warfarin use: ORBACTIV has been shown to artificially prolong PT and 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 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

INDICATION

ORBACTIV® (oritavancin) is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) 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).

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