Lefamulin

(Xenleta®)

Xenleta®

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 150 mg/15 mL of 0.9% sodium chloride); Tablet (oral: 600 mg)
Drug ClassPleuromutilin antibacterials
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms.

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Summary
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  • Xenleta (lefamulin) is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms.
  • This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
  • Omadacycline demonstrated the highest clinical and microbiological treatment success among 20 antimicrobial treatments for complicated skin and soft tissue infections (cSSTIs) across 48 trials involving 24,381 patients, with avarofloxacin being the next most effective treatment.
  • Lefamulin was less effective in clinical and microbiological treatment success compared to omadacycline and avarofloxacin, although it remains a viable option for treatment.
  • Subgroup analyses indicated that the effectiveness of omadacycline, avarofloxacin, and lefamulin was consistent across different population subgroups, though specific details about these subgroups were not provided.
  • Lefamulin (Xenleta) was associated with the lowest risk of severe adverse events, making it the safest option among the drugs assessed.
  • Omadacycline, while having the highest beneficial effect on clinical and microbiological treatment success, was associated with a moderately safe profile.

Product Monograph / Prescribing Information

Document TitleYearSource
Xenleta (lefamulin) Prescribing Information2021Nabriva Therapeutics US Inc., Fort Washington, PA

Systematic Reviews / Meta-Analyses