Lefamulin
Lefamulin is a pleuromutilin-class antibiotic used to treat community-acquired bacterial pneumonia (CABP) in adults. It works by inhibiting bacterial protein synthesis through binding to the 50S ribosomal subunit, targeting a site distinct from other antibiotic classes. This makes it an option for patients with suspected bacterial pneumonia, particularly when other treatments may not be suitable.
Lefamulin is a novel pleuromutilin antibiotic used to treat community-acquired bacterial pneumonia in adults by inhibiting bacterial protein synthesis.
Key facts at a glance
- ATC
- J01XX12
- RxNorm
- 2198944
- Generic
- Lefamulin
- Class
- atc-j01
- Brands
- Xenleta
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- injection, tablet
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 600mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- not approved for pediatric use
- Maximum
- consult physician
- Frequency
- not applicable
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 600mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
10 groupspregnancy
first trimesteravoid if possible
use only if potential benefits justify potential risk to fetus
regular prenatal monitoring
Use with caution and monitor for adverse effects.
pregnancy
second trimesteravoid if possible
use only if potential benefits justify potential risk to fetus
regular fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
use only if potential benefits justify potential risk to fetus
fetal monitoring and assessment of labor
Use with caution and monitor for adverse effects.
lactation
breastfeedinguse with caution
discontinue breastfeeding or discontinue drug considering importance of drug to mother
monitor infant for adverse effects
pediatric_age
under 18 yearsnot recommended
safety and efficacy not established in patients under 18 years
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderlyno dose adjustment required
use with caution due to potential age-related renal/hepatic impairment
monitor renal and hepatic function
Use with caution and monitor for adverse effects.
renal_impairment
mild moderateno dose adjustment required
no dose adjustment needed for mild to moderate renal impairment
routine monitoring
renal_impairment
severeuse with caution
use with caution in severe renal impairment
monitor renal function closely
Use with caution and monitor for adverse effects.
hepatic_impairment
mild moderateno dose adjustment required
no dose adjustment needed for mild to moderate hepatic impairment
routine monitoring
hepatic_impairment
severeuse with caution
use with caution in severe hepatic impairment
monitor hepatic function closely
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Chemical class of antibiotics
FDA approval year
FDA approval date for Lefamulin (Xenleta)
Primary indication
Main therapeutic use
First in class
Novel mechanism of action
Lefamulin is indicated for the treatment of community-acquired bacterial pneumonia (CABP) in adults caused by susceptible strains of Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, and Mycoplasma pneumoniae.
Lefamulin is a pleuromutilin antibiotic that inhibits bacterial protein synthesis by binding to the peptidyl transferase center of the 50S ribosomal subunit. This mechanism targets a distinct site from other antibiotic classes, potentially reducing cross-resistance.
Administered orally or intravenously; common side effects include GI symptoms (nausea, diarrhea, vomiting) and liver enzyme elevations. Use with caution in patients with hepatic impairment. Available only through restricted distribution due to risk of selection for non-susceptible organisms.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy