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Plazomicin

[Plazomicin photo pending]


KEY POINTS

  • Plazomicin (Zemdri) is a “next generation” aminoglycoside antibiotic that has bactericidal concentration-dependent activity and works by inhibiting bacterial protein synthesis
  • Plazomicin is owned by Achaogen, Inc and was FDA-approved on June 26th of 2018 for complicated urinary tract infection in adults
      • The FDA did not approve it for the indication of bloodstream infection in adults
  • Plazomicin is active against some Gram negative bacteria (e.g., E. coli, K. pneumoniae, Enterobacter species) and some Gram positive bacteria (e.g., Staphylococcus aureus, including MRSA)
    • Has reduced activity versus most Pseudomonas aeruginosa and Acinetobacter baumannii isolates
    • Lacks activity against Enterococcus species, Streptococcus species, Stenotrophamonas maltophilia, and obligate anaerobes
    • Plazomicin’s chemical structure allows it to remain active against some carbapenem-resistant organisms other aminoglycosides are inactive against
      • Plazomicin can resist certain aminoglycoside modifying enzymes
      • May not be effective for NDM-containing isolates, due to the frequent presence of aminoglycoside-resistance mechanisms
  • Primarily renal elimination and requires dose adjustment for renal dysfunction
  • Anticipated will be available IV only
  • Anticipated will be once-daily dosing
  • May require therapeutic drug monitoring
  • Carries boxed warnings for: nephrotoxicity, ototixicity, neuromuscular blockade, and fetal harm in pregnant mothers

RESOURCES

  • Plazomicin Package Insert
  • Achaogen’s Plazomicin Page
  • Zemdri FDA Approval Press Release
  • FDA Briefing Document. Plazomicin sulfate Injection Meeting of the Antimicrobial Drugs Advisory Committee (AMDAC). May 02, 2018.
  • Achaogen Announces FDA Advisory Committee Voted Unanimously in Favor of Plazomicin for Treatment of Adults with Complicated Urinary Tract Infections. May 2, 2018.
  • Thaden JT et al. Role of newer and re-emerging older agents in the treatment of infections caused by carbapenem-resistant Enterobacteriaceae. Virulence. 2017; 80(4): 403-416. 
  • Garcia-Salguero C et al. Can Plazomicin Alone or in Combination Be a Therapeutic Option against Carbapenem-Resistant Acinetobacter baumannii? Antimicrobial Agents and Chemotherapy. 2015; 59(10): 5959–5966.
  • Marcelo JR. Plazomicin: Will it be the future of MDRO treatment?  UNMC Division of Infectious Diseases Blog. 2018.


 

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