Article - Antibacterial Drugs (A54812)

CMS National Coverage PolicyN/AArticle TextORBACTIV(oritavancin)Orbactiv(oritavancin) is a semisynthetic lipoglycopeptide antibacterial drug. It exerts concentration-dependent bactericidal activity in vitro againstS. aureus, S. pyogenes, and E. faecalis.Orbactivis specifically indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:Staphylococcus aureus (including methicillin-susceptible and methicillinresistant isolates) Streptococcus pyogenes Streptococcus agalactiae Streptococcus dysgalactiae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Enterococcus faecalis (vancomycin-susceptible isolates only)Orbactivis supplied as a solution for intravenous infusion. The recommended dose is a single 1200 mg dose administered by intravenous infusion over three hours in patients 18 years and older.DALVANCE(dalbavancin)Dalvance(dalbavancin) is a lipoglycopeptide antibacterial drug proposed for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:Staphylococcus aureus (including methicillin-resistant [MRSA] isolates) Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) Enterococcus faecalis (vancomycin-susceptible isolates only)Because of its long elimination half-life, the dosing regimen is 1000 mg on Day 1 and 500 mg on Day 8, administered intravenously (IV) over 30 minutes.VIBATIV(telavancin)Vibativ(telavancin) is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby Vibativ both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. Vibativis specifically indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:Staphylococcus aureus (including methicillin-susceptible and -resistant isolates) Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Enterococcus faecalis(vancomycin-susceptible isolates only) Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates ofStaphylococcus aureus.Vibativis supplied as a powder for reconstitution onto a solution designed for intravenous administration. The recommended initial dose is 10 mg/kg administered over a 60-minute period in patients >18 years of age by intravenous infusion once every 24 hours for 7 to 14 days.SIVEXTRO (tedizolid)Sivextro(tedizolid)is an oxazolidinone-class antibacterial drug indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:Staphylococcus aureus (including methicillin-susceptible and methicillinresistant isolates) Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus) Enterococcus faecalis(vancomycin-susceptible isolates only).The recommended dosage is 200 mg administered once daily for 6 days.Sivextrocanbe given orally (with or without food) or as an intravenous (IV) infusion over 1 hour for patients 18 years of age or older.To reduce the development of drug-resistant bacteria and maintain the effectiveness of these drugs-oritavancin, dalbavancin, telavancin and tedizolid should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.