Generic Name and Formulations:
Oritavancin 400mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains mannitol; preservative-free.
Indications for ORBACTIV:
Acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible Gram (+) microorganisms: Staphylococcus aureus (including MRSA and MSSA), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, Streptococcus constellatus) and Enterococcus faecalis (vancomycin-susceptible isolates only).
Give by IV infusion over 3hrs. ≥18yrs: 1200mg as a single dose.
<18yrs: not established.
Use of IV unfractionated heparin sodium for 120hrs (5 days) after oritavancin administration.
History of glycopeptide allergy. Discontinue immediately if acute hypersensitivity reaction occurs. Consider slowing or stopping infusion if infusion-related reactions occur. Risk of Clostridium difficile-associated diarrhea; evaluate and may need to discontinue if occurs. Monitor for signs/symptoms of osteomyelitis; use alternative therapy if suspected or diagnosed. Severe hepatic or renal impairment: not studied. Pregnancy (Cat.C). Nursing mothers.
Increased risk of bleeding with concomitant warfarin; may prolong aPTT for up to 120hrs, PT/INR for up to 12hrs, and ACT for up to 24hrs; monitor for bleeding. Avoid concomitant drugs with a narrow therapeutic window that are metabolized by the affected CYP450 enzymes. May increase concentrations of CYP2C9/CYP2C19 substrates. May decrease concentrations of CYP3A4/CYP2D6 substrates. May interfere with coagulation tests; consider non-phospholipid dependent test (eg, Factor Xa assay) or alternative anticoagulant not requiring aPTT monitoring.
Headache, nausea, vomiting, limb and subcutaneous abscesses, diarrhea; infusion-related reactions.
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