Plazomicin

(Zemdri®)

Zemdri®

Drug updated on 9/4/2024

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.

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Summary
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  • Zemdri (plazomicin) is indicated for the treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including pyelonephritis.
  • This summary is based on the review of one randomized controlled trial(s). [1]
  • Day 5 Composite Cure Rates for complicated UTIs and acute pyelonephritis: Plazomicin achieved a cure rate of 88.0% (168/191) compared to 91.4% (180/197) with meropenem, with a difference of -3.4 percentage points (95% CI, -10.0 to 3.1).
  • Test-of-Cure Composite Cure Rates (15 to 19 days after initiation): Plazomicin had a cure rate of 81.7% (156/191) versus 70.1% (138/197) with meropenem, showing a difference of 11.6 percentage points (95% CI, 2.7 to 20.3).
  • Late Follow-Up Outcomes (24 to 32 days after initiation): Plazomicin resulted in lower microbiologic recurrence (3.7%) and clinical relapse (1.6%) compared to meropenem, which had rates of 8.1% and 7.1%, respectively.
  • An increase in serum creatinine levels (≥0.5 mg/dL above baseline) was observed in 7.0% of patients treated with plazomicin, compared to 4.0% in those treated with meropenem.
  • There is no population types or subgroups information available in the reviewed studies.

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