The U.S. Food and Drug Administration (FDA) has approved XENLETA (lefamulin) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
The approved recommended dosage of XENLETA is as follows:
- XENLETA Injection: 150 mg every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days, with the option to switch to XENLETA Tablets 600 mg every 12 hours to complete the treatment course.
- XENLETA Tablets: 600 mg orally every 12 hours for 5 days.
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Administer XENLETA Tablets at least 1 hour before a meal or 2 hours after a meal. XENLETA is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA. Concomitant use of XENLETA Tablets with sensitive CYP3A substrates known to prolong the QT interval is contraindicated.
Additional information regarding dosage and administration as well as important warnings and precautions about QT prolongation, embryo-fetal toxicity, Clostridium difficile-associated diarrhea, and the risk of the development of drug-resistant bacteria can be found in the full prescribing information linked below.