Drug updated on 4/18/2024
| Dosage Form | Injection (intravenous; 150 mg/15 mL of 0.9% sodium chloride); Tablet (oral: 600 mg) |
| Drug Class | Pleuromutilin antibacterials |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms.
Summary
- Lefamulin (Xenleta) is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) and has been compared with other antimicrobial therapies in terms of efficacy and safety, particularly for complicated skin and soft tissue infections (cSSTIs).
- The information derives from a single systematic review/meta-analysis.
- In terms of efficacy, lefamulin was found to be less effective than omadacycline and avarofloxacin. These two drugs showed higher clinical and microbiological treatment success rates for cSSTIs.
- However, lefamulin outperformed both omadacycline and avarofloxacin in safety profile, being associated with the lowest risk of severe adverse events among all studied antimicrobial treatments.
- While no specific subgroups or population types were mentioned in the study reviewed, it indicated that findings regarding both efficacy and safety were consistent across subgroup analyses. This suggests that lefamulin's superior safety profile may be applicable across diverse patient profiles.
- Despite these promising results about its favorable safety profile over other antibiotics used against cSSTIs, caution is advised due to moderate-to-low quality evidence supporting these conclusions, as stated in the systematic review/meta-analysis.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Xenleta (lefamulin) Prescribing Information | 2021 | Nabriva Therapeutics US Inc., Fort Washington, PA |