Lefamulin is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms, among other approved uses. It is available as injection and tablets for intravenous and oral use. MedsAcross supplies Lefamulin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. 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 bacteria.
Source: US FDA prescribing information
XENLETA is an antibacterial drug.
Source: US FDA prescribing information
For treatment of adults with CABP, the recommended dosage of XENLETA is as follows: *With the option to switch to XENLETA Tablets 600 mg every 12 hours to complete the treatment course. Dosage Treatment Duration 150 mg every 12 hours by intravenous infusion over 60 minutes* 5 to 7 days 600 mg orally every 12 hours. 5 days Patients with Hepatic Impairment: Reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours in patients with severe hepatic impairment (Child-Pugh Class C). XENLETA Tablets have not been studied in and are not recommended for patients with moderate (Child-Pugh Class B) or severe hepatic impairment. Administration Instruction for XENLETA Tablets: Take at least 1 hour before a meal or 2 hours after a meal. Swallow XENLETA Tablets whole with water (6 to 8 ounces). Administration Instruction for XENLETA Injection: Infuse over 60 minutes.
Source: US FDA prescribing information
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 CYP3A substrates that prolong the QT interval is contraindicated.
Source: US FDA prescribing information
QT Prolongation: Avoid use in patients with known QT prolongation, ventricular arrhythmias including torsades de pointes, and patients receiving drugs that prolong the QT interval such as antiarrhythmic agents. Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. Clostridioides difficile -associated Diarrhea (CDAD): Evaluate patients who develop diarrhea.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: QT Prolongation. Clostridioides difficile -associated Diarrhea. Most common adverse reactions (incidence ≥2%) are: XENLETA Injection: administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, headache. XENLETA Tablets: diarrhea, nausea, vomiting, hepatic enzyme elevation.
Source: US FDA prescribing information
XENLETA Injection Strong or moderate CYP3A inducers or P-gp inducers Avoid XENLETA unless the benefit outweighs the risk. Monitor for reduced efficacy. XENLETA Tablets Strong or moderate CYP3A inducers or P-gp inducers Avoid XENLETA unless the benefit outweighs the risk. Strong CYP3A inhibitors or P-gp inhibitors Avoid XENLETA. Moderate CYP3A inhibitors or P-gp inhibitors Monitor for adverse reactions. CYP3A substrates that prolong the QT interval Concomitant use is contraindicated. Midazolam and other sensitive CYP3A substrates Monitor for adverse reactions.
Source: US FDA prescribing information
XENLETA Injection should be stored at 2°C to 8°C (36°F to 46°F). Store in a refrigerator. Do not freeze. The diluent bags should be stored in barrier overwrap at 2°C to 25°C (36°F to 77°F) until ready to use. They are supplied as follows: NDC Xenleta (lefamulin) tablets Package Factor 71288- 037 -10 600 mg tablets 10 tablets per blister card Storage and Handling XENLETA Tablets should be stored at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Lefamulin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Xenleta 150 mg/15 mL injectionIntravenous Cold chain | Meitheal Pharmaceuticals | US FDA | Available on request |
| Xenleta 600 mg tabletOral Cold chain | Meitheal Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Lefamulin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Lefamulin, including Xenleta.
Yes. The US FDA first approved Lefamulin on 19 August 2019, according to Drugs@FDA.
Yes. Lefamulin has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Lefamulin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Lefamulin is classified under ATC code J01XX (Antibiotics for systemic use, subgroup J01X, subgroup J01XX).
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