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®.
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.
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, including anaphylaxis, 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. Infusion reactions characterized by chest pain, back pain, chills and tremor have been observed with the use of ORBACTIV®, including after the administration of more than one dose of ORBACTIV® during a single course of therapy. 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.
The most common adverse reactions (≥3%) in patients treated with ORBACTIV® were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.