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Lefamulin (Xenleta)

[Lefamulin photo pending]

KEY POINTS

  • Lemafulin (Xenleta, formerly BC-3781) is a pleuromutilin antibiotic that inhibits bacterial protein synthesis by binding to the peptidyl transferase center of the 50S bacterial ribosome, which in turn prevents the binding of transfer RNA for peptide transfer
    • Exhibits time-dependent killing with ƒAUC0–24/MIC as the best pharmacodynamic target
  • FDA approved August 19, 2019 to treat adults with community-acquired bacterial pneumonia
    • Was approved through the FDA’s Qualified Infectious Diseases Product designation
  • Available IV or PO
    • Dosed 150mg BID for IV and 600mg BID for oral
      • Tablet formulation is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh Class B or C), lack of data
      • IV formulation frequency should be changed from BID to daily in patients with severe hepatic impairment (Child-Pugh Class C)
  • Displays activity versus…
    • Gram positives (e.g., Streptococcus pneumoniae, Staphylococcus aureus [including MRSA], Enterococcus faecium [including VRE], coagulase negative staphylococci, beta-hemolytic streptococci, viridans group streptococci)
    • Gram negatives (e.g., Haemophilus influenzae, Neisseria gonorrhoeae, Moraxella catarrhalis)
      • Gram negative coverage is somewhat limited
    • Atypicals (e.g., Mycoplasma pneumoniae, Legionella pneumophila, and Chlamydophila pneumoniae, Mycoplasma genitalium)
  • The most common side effects known to date include liver enzyme elevation, nausea, vomiting, diarrhea, and injection site reactions
  • Has the potential to prolong QT interval
  • Has the potential to cause fetal harm, beware use in pregnant women

RESOURCES

  • Lefamulin Package Insert
  • Lefamulin FDA Approval Alert
  • Xenleta Nabriva Press Release
  • Journal of Antimicrobial Chemotherapy’s 2019 Supplement 3: Focus on Lefamulin
  • Lefamulin: Review of a Promising Novel Pleuromutilin Antibiotic. Pharmacotherapy. 2018.
  • Therapeutic potential of lefamulin in the treatment of community acquired pneumonia. Future Micro 2019


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