Lefamulin (Lefabac) 600 mg, 10 film-coated tablets: profile, composition and research
Reference page for Lefamulin (Lefabac) 600 mg, 10 film-coated tablets. Active substance: Лефамулин / Lefamulin.
- What it is: lefamulin, a systemic antibiotic of the pleuromutilin class.
- Presentation: film-coated tablets of 600 mg, 10 tablets.
- Status: prescription-only medicine.
- Research: the LEAP trial programme in community-acquired pneumonia, links below.
- Where to buy: APV Pharmacy (price and availability there).
Key facts
| Active substance | Lefamulin (as acetate) |
|---|---|
| Form | Film-coated tablets |
| Strength | 600 mg per tablet |
| Pack size | 10 tablets |
| Category | Prescription antibiotic |
| Article (SKU) |
What lefamulin is
Lefamulin is a systemic antibiotic of the pleuromutilin class. It is supplied as 600 mg tablets; a pack contains 10 film-coated tablets.
For a long time pleuromutilins were used mainly in veterinary medicine and topically. Lefamulin became the first agent of this class intended for oral and intravenous use in people.
This is a prescription product. It is prescribed for bacterial pneumonia acquired outside hospital and is used only on a physician's instruction.
How lefamulin works
The target in the bacterial cell
Lefamulin binds to the 50S subunit of the bacterial ribosome, the cell's protein factory. This prevents the bacterium from making its own proteins.
Blocking protein synthesis
Because protein synthesis stops, the bacterial cell loses the ability to grow and divide. The mechanism is described as bacteriostatic, and at high concentrations it can become bactericidal.
Why it matters
The binding site of lefamulin differs from the one used by macrolides and fluoroquinolones, so the medicine keeps its activity against many resistant strains.
Approved uses
The prescribing information names community-acquired bacterial pneumonia in adults caused by susceptible microorganisms. Among them are pneumococcus, methicillin-susceptible Staphylococcus aureus, Haemophilus influenzae, Legionella, Mycoplasma and Chlamydophila.
The medicine is made both for intravenous use and as tablets, which allows a switch from infusion to oral intake when appropriate.
The decision to prescribe, the choice of form and the length of treatment are the physician's. Antibacterial therapy is not started on one's own, all the more so because pneumonia has to be confirmed clinically and in the laboratory.
What the research shows
The clinical trial programme for the medicine is called LEAP. In the LEAP 1 and LEAP 2 studies lefamulin was compared with a combination of another antibiotic with a beta-lactamase inhibitor in adults with community-acquired pneumonia.
In the published results lefamulin showed comparable efficacy by the criteria of clinical response; good tolerability was reported, alongside a possible prolongation of the QT interval.
Reviews stress that the data on the medicine are still limited and come from relatively short studies. In clinical guidance it is therefore regarded as one option rather than a universal remedy.
Published research
Primary sources, verified against PubMed:
- Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial., PubMed 30722059 (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019).
- Lefamulin: A Novel Semisynthetic Pleuromutilin Antibiotic for Community-acquired Bacterial Pneumonia., PubMed 32221520 (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020).
- Lefamulin: A Novel Oral and Intravenous Pleuromutilin for the Treatment of Community-Acquired Bacterial Pneumonia., PubMed 33247830 (Drugs, 2021).
- Lefamulin: Review of a Promising Novel Pleuromutilin Antibiotic., PubMed 30019769 (Pharmacotherapy, 2018).
Listed for reference. Publication of a study is not a claim about this particular product.
Precautions
- This is a prescription medicine. The decision to prescribe and the length of treatment belong to a physician.
- Lefamulin can prolong the QT interval, so it is not used in known QT prolongation, ventricular arrhythmias or a low blood potassium level.
- In pregnancy the medicine can harm the fetus; pregnancy should be excluded before treatment starts.
- Strong and moderate inducers of CYP3A enzymes and of P-glycoprotein reduce the effect of lefamulin, so your doctor must be told about every medicine you take.
- Nausea, diarrhoea, vomiting, headache, insomnia and raised liver enzymes are possible. Severe or persistent diarrhoea calls for medical advice.
- It is not recommended in severe hepatic impairment.
Frequently asked
Is lefamulin a prescription medicine?
Yes. It is a prescription antibiotic and is not intended for use on one's own.
Which pathogens does the medicine act against?
Pneumococcus, methicillin-susceptible Staphylococcus aureus, Haemophilus influenzae, Legionella, Mycoplasma and Chlamydophila, as well as a number of resistant strains. Susceptibility is determined in the laboratory.
Why does this page not give a dosing schedule?
The dose, the form and the length of the course are set by a physician with the diagnosis and the patient's condition in mind. A reference page does not prescribe treatment.
Where does the order ship from?
Shipping and customs handling are described on the APV Pharmacy delivery page.