Plazomicin

(Zemdri®)

Zemdri®

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Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 500 mg/ 10mL [50 mg/mL] in a single-dose vial containing plazomicin sulfate equivalent to 500 mg plazomicin free base)
Drug ClassAminoglycoside antibacterials
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI) including pyelonephritis.

Summary
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  • Plazomicin (Zemdri) is indicated for the treatment of patients 18 years or older with complicated urinary tract infections (cUTI), including pyelonephritis.
  • The information was derived from a single study, which was a randomized controlled trial comparing plazomicin to meropenem in treating cUTIs.
  • In terms of effectiveness, at day 5, clinical cure and microbiologic eradication were slightly lower in the plazomicin group compared to the meropenem group. However, by the test-of-cure visit time point, plazomicin showed superior results in composite cure rates and higher microbiologic eradication rates among resistant Enterobacteriaceae.
  • There is an increased risk of nephrotoxicity with Zemdri as demonstrated by elevated serum creatinine levels compared to those treated with meropenem.
  • While specific subgroup data are not detailed within this study beyond adults aged 18 years or older suffering from cUTIs caused by multidrug-resistant Enterobacteriaceae; it suggests that Zemdri may be suitable for these individuals.
  • Despite its potential nephrotoxicity risks, Plazomicin represents a valuable option particularly where multidrug-resistant pathogens are involved but requires careful consideration depending on individual patient risk factors and susceptibilities.

Product Monograph / Prescribing Information

Document TitleYearSource
Zemdri (plazomicin) Prescribing Information.2020Cipla USA, Inc., Warren, NJ

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Once-daily plazomicin for complicated urinary tract infections.
388Subjects
F: 53%
M: 47%
2019New England Journal of Medicine

Sex Distribution:

F:53%
M:47%
388Subjects

Year:

2019

Source:New England Journal of Medicine

Clinical Practice Guidelines