Xenleta
Authorised
This medicine is authorised for use in the European Union
lefamulin
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Xenleta is an antibiotic used in adults to treat community-acquired pneumonia (a lung infection caught outside of hospital) when other antibiotic medicines are not suitable or do not work.
Xenleta contains the active substance lefamulin.
Xenleta can only be obtained with a prescription, and official guidelines on the use of antibiotics should be considered by the prescribing doctor.
Xenleta can be given by mouth as tablets or by infusion (drip) into a vein.
The recommended dose for Xenleta tablets is 600 mg every 12 hours, taken at least 1 hour before or 2 hours after a meal. The duration of treatment is 5 days.
Xenleta infusion is given over 1 hour at a dose of 150 mg every 12 hours. Treatment may be switched to Xenleta tablets and the total duration of treatment is 7 days.
For more information about using Xenleta, see the package leaflet or contact your doctor or pharmacist.
The active substance in Xenleta, lefamulin, belongs to a group of medicines called pleuromutilins. Lefamulin interferes with bacterial RNA (genetic material), blocking the production of bacterial proteins. This prevents the bacteria from multiplying and they eventually die.
Xenleta was tested in two main studies involving 1,282 adults with community-acquired pneumonia. Both studies showed that Xenleta was as effective as moxifloxacin (another antibiotic).
In the first study patients were either given Xenleta infusion and then switched to Xenleta tablets, or moxifloxacin infusion and then switched to moxifloxacin tablets. In both cases, treatment with infusion continued for at least 3 days and the total duration of treatment was 5 to 7 days for Xenleta and 7 to 10 days for moxifloxacin. Cure rates were similar in the two groups: 82% of patients treated with Xenleta and 84% of those treated with moxifloxacin had no signs of infection 5 to 10 days after the last dose.
In the second study, patients were given Xenleta tablets for 5 days or moxifloxacin tablets for 7 days. Xenleta was as effective as moxifloxacin at curing the infection: 88% of patients treated with Xenleta and 89% of those treated with moxifloxacin had no signs of infection 5 to 10 days after the last dose.
The most common side effects with Xenleta (which may affect up to 1 in 10 people) are redness, pain or swelling at the site of the infusion; diarrhoea, nausea (feeling sick), or vomiting (mostly with tablets); raised levels of liver enzymes (a sign of liver problems), headache, hypokalaemia (low potassium levels in blood), and insomnia (difficulty sleeping).
The most common serious reaction, in less than 1 in 10 patients, is atrial fibrillation (an abnormal rapid rhythm of the upper chambers of the heart).
Xenleta should not be used in patients who are hypersensitive (allergic) to the active substance in Xenleta or any other pleuromutilin antibiotic. It should not be taken together with certain medicines that might cause interactions that can alter the effect of Xenleta or the other medicines.
Xenleta must not be given to patients with prolonged QT interval (abnormal electrical activity of the heart that affects its rhythm) or who take medicines that prolong QT interval, or who have a salt imbalance in the blood (especially low potassium levels). It should also not be given to patients with heart problems such as abnormal heart rhythm or heart failure (when the heart does not work well enough).
For the full list of side effects and restrictions with Xenleta, see the package leaflet.
Studies found that Xenleta was as effective as moxifloxacin at treating community-acquired pneumonia. Its side effects were considered manageable. Therefore, the European Medicines Agency decided that Xenleta’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xenleta have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Xenleta are continuously monitored. Side effects reported with Xenleta are carefully evaluated and any necessary action taken to protect patients.
Xenleta received a marketing authorisation valid throughout the EU on 27 July 2020.
Product information
Latest procedure affecting product information:
IB/0005
23/06/2021
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Xenleta
- Active substance
- lefamulin acetate
- International non-proprietary name (INN) or common name
- lefamulin
- Therapeutic area (MeSH)
- Pneumonia, Bacterial
- Community-Acquired Infections
- Anatomical therapeutic chemical (ATC) code
- J01XX
Pharmacotherapeutic group
Antibacterials for systemic useTherapeutic indication
Xenleta is indicated for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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