Lefamulin
Pronunciation: (zen-LEE-tah).
- Generic name
- lefamulin
- Brand names
- Lefabact, Lefaxen, Xenleta, Lefamulin
- Drug class
- Antibiotic (Pleuromutilin class)
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What lefamulin is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how lefamulin works
Lefamulin inhibits bacterial protein synthesis by binding to the peptidyl transferase center of the 50S ribosomal subunit, interfering with peptide bond formation. This unique binding site is distinct from other antibiotic classes, reducing cross-resistance. (1) (2)
What lefamulin is used for
Community-acquired bacterial pneumonia (CABP)
Community-acquired bacterial pneumonia (CABP) (2)
Before taking lefamulin
Do not take / not appropriate for
- Contraindicated in patients with known hypersensitivity to lefamulin or excipients, and in those taking strong CYP3A4 inducers (e.g., rifampin) or inhibitors (e.g., ketoconazole). (Contraindication) (2)
Tell your clinician about
(2)How to take lefamulin
- General Instructions: Take Xenleta exactly as prescribed by your healthcare provider. Do not skip doses or stop early, even if you feel better.. Adult Dosing: The usual adult dose is 600 mg by mouth every 12 hours for 5 days, or 150 mg intravenously every 12 hours for 5 to 7 days, depending on the severity of the infection.. Pediatric Dosing: Safety and effectiveness in children under 18 years have not been established; Xenleta is not recommended for pediatric use.. Administration: Oral tablets should be taken at least 1 hour before or 2 hours after a meal. IV infusions are administered by a healthcare professional.. When To Stop: Complete the full course unless your doctor tells you to stop. Discontinue and seek medical advice if you develop severe side effects or allergic reactions.. Storage: Store tablets at room temperature, away from moisture and heat. Follow healthcare facility protocols for IV storage.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose—do not double up. Contact your doctor if you miss more than one dose.
Overdose
In case of overdose, seek emergency medical attention or call your local poison control center. Symptoms may include severe nausea, vomiting, or abnormal heart rhythms. Supportive care is recommended as there is no specific antidote. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Diarrhea
Incidence: Reported in the clinician-authored database; frequency not established
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Vomiting
Incidence: Reported in the clinician-authored database; frequency not established
Headache
Incidence: Reported in the clinician-authored database; frequency not established
QT prolongation
Incidence: Reported in the clinician-authored database; frequency not established
Clostridioides difficile-associated diarrhea
Incidence: Reported in the clinician-authored database; frequency not established
Hypersensitivity reactions
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
May cause QT interval prolongation and serious heart rhythm disturbances — serious
Symptoms: May cause QT interval prolongation and serious heart rhythm disturbances. Use with caution in patients with liver impairment. Not recommended during pregnancy or breastfeeding unless clearly needed. May interact with other medications metabolized by CYP3A4. Risk of Clostridioides difficile-associated diarrhea.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindicated in patients with known hypersensitivity to lefamulin or excipients, and in those taking strong CYP3A4 inducers (e.g., rifampin) or inhibitors (e.g., ketoconazole). Use caution in patients with hepatic impairment, QT prolongation, or those on QT-prolonging drugs.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Xenleta can interact with drugs that affect liver enzymes (CYP3A4), such as rifampin, certain antifungals, and some anti-seizure medications. It may also interact with drugs that prolong the QT interval (e.g., some antiarrhythmics, antipsychotics, and macrolide antibiotics). Always inform your healthcare provider of all medications and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Requires a primary-source research pass before this section can be completed. (2)
Breastfeeding
Requires a primary-source research pass before this section can be completed. (2)
Children
Frequency: Not applicable. Weight Based: Not recommended for pediatric use. Max Daily Dose: Not applicable. Max Single Dose: Not applicable. Age Restrictions: Safety not established in children (2)
Renal_impairment
Requires a primary-source research pass before this section can be completed. (2)
Hepatic_impairment
Requires a primary-source research pass before this section can be completed. (2)
Monitoring
(2)Storage
Requires a primary-source research pass before this section can be completed.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Community-acquired bacterial pneumonia (CABP)
Dose summary: 600 mg administered intravenously or orally every 12 hours for 5-7 days.
Renal context: FDA label (Xenleta): no clinically significant differences in lefamulin pharmacokinetics were observed based on renal impairment, including in patients receiving hemodialysis, so no dosage adjustment is warranted for renal impairment (either formulation). Note the label separately flags that metabolic disturbances associated with renal failure requiring dialysis may contribute to QT prolongation, which is relevant to lefamulin's own QT-prolongation warning. (1) (2)
Hepatic guidance
FDA label (Xenleta): hepatic-impairment dosing differs by formulation. For the IV injection, the labeled dose for severe hepatic impairment (Child-Pugh Class C) is a lower 150 mg infused over 60 minutes every 24 hours, as directed by the prescriber; no adjustment is specified for mild/moderate hepatic impairment with the injection. The oral tablet formulation is not recommended in patients with moderate or severe hepatic impairment. Metabolic disturbances associated with any degree of hepatic impairment (mild, moderate, or severe) may contribute to QT prolongation.
Frequently asked questions
What is Xenleta used for?
Xenleta is used to treat adults with community-acquired bacterial pneumonia (CABP), a type of lung infection caused by certain bacteria.
How does Xenleta work?
Xenleta works by blocking bacterial protein synthesis, which stops the bacteria from growing and multiplying. This helps your body fight the infection.
Can I take Xenleta if I have liver disease?
If you have liver disease, your doctor may need to adjust your dose or monitor you more closely. Severe liver impairment is a contraindication for Xenleta.
Is Xenleta safe during pregnancy or breastfeeding?
Xenleta is not recommended during pregnancy or breastfeeding unless the benefits outweigh the risks. Discuss with your doctor if you are pregnant or nursing.
What should I do if I experience severe diarrhea while taking Xenleta?
Contact your doctor immediately, as severe diarrhea may be a sign of a serious intestinal infection (C. difficile-associated diarrhea).
Can children take Xenleta?
Xenleta is not approved for use in children under 18 years of age.
Are there any foods or drinks I should avoid while taking Xenleta?
Take oral Xenleta tablets at least 1 hour before or 2 hours after eating. Avoid alcohol and grapefruit products, as they may increase side effects or affect drug levels.
What happens if I take too much Xenleta?
Taking too much Xenleta (lefamulin) may lead to an increased risk and severity of side effects, particularly gastrointestinal issues like severe nausea, vomiting, or diarrhea. In cases of suspected overdose, it is crucial to seek immediate emergency medical attention. Healthcare professionals can provide supportive care and manage any adverse reactions effectively.
Can I drink alcohol while taking Xenleta?
While there are no specific contraindications against alcohol consumption with Xenleta (lefamulin), it is generally advisable to limit or avoid alcohol. Alcohol can exacerbate common side effects such as nausea, vomiting, and diarrhea, which are also associated with Xenleta. Additionally, alcohol can potentially impact your body's ability to fight infection and may interfere with your recovery.
Is Xenleta safe during pregnancy?
The safety of Xenleta (lefamulin) during pregnancy has not been definitively established. It is categorized as a drug where the risks to the fetus cannot be ruled out. Therefore, if you are pregnant, planning to become pregnant, or breastfeeding, it is essential to consult your doctor before taking Xenleta. Your healthcare provider can assess the potential benefits and risks to make an informed decision.
What is the mechanism of action of lefamulin?
Lefamulin inhibits bacterial protein synthesis by binding to the peptidyl transferase center of the 50S ribosomal subunit, interfering with peptide bond formation. This unique binding site is distinct from other antibiotic classes, reducing cross-resistance. (1) (2)
What is the generic name of Lefamulin?
The generic name is lefamulin. It is sold under brand names including Lefabact, Lefaxen, Xenleta, Lefamulin.
What class of drug is lefamulin?
Lefamulin is classed as: Antibiotic (Pleuromutilin class).
References
- Clinician-authored medicine record for Xenleta (MedGuideGlobal medicines database) · · accessed 2026-08-07 · source 1
- XENLETA (lefamulin) injection and tablets — FDA prescribing information, DailyMed · · accessed 2026-08-07 · source 2
- XENLETA (LEFAMULIN ACETATE) INJECTION, SOLUTION CITRIC BUFFERED NORMAL SALINE (ANHYDROUS CITRIC ACID) INJECTION, SOLUTION XENLETA (LEFAMULIN ACETATE) TABLET, COATED [MEITHEAL PHARMACEUTICALS INC.] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- Xenleta — FDA approval record (Drugs@FDA NDA211672)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- lefamulin — RxNorm normalized drug concept (RXCUI 2198943)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient lefamulin names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Xenleta600 mg, 150 mg5mL · meitheal pharmaceuticals inc.