[Plazomicin photo pending]
- 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
- Plazomicin Package Insert
- Achaogen’s Plazomicin Page
- Zemdri FDA Approval Press Release
- Plazomicin EU Marketing Application Is Withdrawn: Near Zero Market Value Of Newly Approved Antibacterials
- 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.