Important Safety Information
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
Concomitant warfarin use: Co-administration of ORBACTIV® and warfarin may result in higher exposure of warfarin, which may increase the risk of bleeding. Use ORBACTIV® in patients on chronic warfarin therapy only when the benefits can be expected to outweigh the risk of bleeding.
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.
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 the development of drug-resistant bacteria.
The most common adverse reactions (≥ 3%) in patients treated with ORBACTIV® were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.
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