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Meropenem-vaborbactam (Vabomere)

[Meropenem-vaborbactam photo]

KEY POINTS

  • Meropenem-vaboractam (Vabomere, formerly Carbavance) is the combination of carbapenem (meropenem) plus beta-lactamase inhibitor (vaborbactam)
    • Meropenem interferes with bacterial cell wall synthesis in susceptible pathogens through interference with penicillin binding proteins
    • Vaborbactam alone has no antimicrobial activity and is a novel cyclic boronic acid inhibitor of numerous class A and class C enzymes
      • Designed as a potent inhibitor of serine carbapenemases
    • A fixed-dose combination product studied for complicated urinary tract infection and other drug-resistant infections
  • Meropenem-vaborbactam was FDA-Approved on August 29th 2017
    • Approved for complicated urinary tract infection including pyelonephritis
    • The first carbapenem-betalactamase inhibitor combination approved in the United States
    • The only antibiotic product in the United States including beta-lactamase inhibitor vaborbactam
  • Meropenem has broad-spectrum Gram negative coverage, including multi-drug resistant organisms
  • The addition of vaborbactam mainly extends the spectrum of meropenem to include some carbapenem-resistant organisms
    • Highly active against many carbapenem-resistant Enterobacteriaceae (CRE)
    • Not found to expand coverage to carbapenem-resistant  Acinetobacter baumannii, Pseudomonas aeruginosa, or Stenotrophomonas maltophilia
  • The TANGO-2 trial comparing meropenem-vaborbactam to best available therapy was stopped early due to a risk-benefit ratio in favor of meropenem-vaborbactam
  • Most likely a drug that will be reserved for CRE
  • Dose is 4 grams IV every 8 hours as a 3-hour infusion in adults
    • Available intravenous only
    • Adjust doses for renal function
    • Dose adjustment for hepatic function not recommended in package insert
  • Common side effects in trials were headache, infusion site reactions, and diarrhea
  • Has the potential to cause serious side effects such as seizure or anaphylaxis
  • Beware drug interaction with valproic acid
  • Beware short stability once mixed for administration
    • Infusion should be completed within 4 hours if stored at room temperature
    • Infusion should be completed within 22 hours if stored under refrigeration
  • Anticipated that this drug will be very expensive
  • Reserve use to preserve it for when it is truly needed (e.g., CRE)

RESOURCES

  • Meropenem-vaborbactam Package Insert
  • FDA-Approval Announcement for Meropenem-Vaborbactam
  • PRESS RELEASE: The Medicines Company announces TANGO-2 trial of meropenem-vaborbactam (formerly, Carbavance) stopped early for superior benefit-risk compared to best available therapy for CRE [July 2017]
  • Meropenem-Vaborbactam (M-V) Compared with Piperacillin-Tazobactam (P-T) in the Treatment of Adults with Complicated Urinary Tract Infections (cUTI), including Acute Pyelonephritis (AP) in a Phase 3 Randomized, Double-blind, Double-dummy Trial (TANGO 1) [IDSA 2016]
  • Role of newer and re-emerging older agents in the treatment of infections caused by carbapenem-resistant Enterobacteriaceae (Virulence 2017)
  • Effect of the β-Lactamase Inhibitor Vaborbactam Combined with Meropenem against Serine Carbapenemase-Producing Enterobacteriaceae (Antimicrobial Agents and Chemotherapy 2016)
  • Meropenem–Vaborbactam Tested against Contemporary Gram-Negative Isolates Collected Worldwide During 2014, Including Carbapenem-Resistant, KPC-Producing, Multidrug-Resistant, and Extensively Drug-Resistant Enterobacteriaceae.(Antimicrobial Agents and Chemotherapy 2017)

Photo credit: www.vabomere.com




 

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