Is Lefamulin approved by the FDA?
Yes, lefamulin is FDA approved. Lefamulin, marketed under the brand name Xenleta, is a novel antibiotic used to treat community-acquired bacterial pneumonia (CABP) in adults. The U.S. Food and Drug Administration (FDA) approved lefamulin on August 19, 2019, making it the first pleuromutilin antibiotic available for systemic administration in humans.
What is Lefamulin?
Lefamulin is an antibiotic belonging to the pleuromutilin class, which works by inhibiting bacterial protein synthesis, thereby stopping bacterial growth. It is effective against a range of pathogens responsible for pneumonia, including:
- Streptococcus pneumoniae
- Staphylococcus aureus (methicillin-susceptible isolates)
- Haemophilus influenzae
- Legionella pneumophila
- Mycoplasma pneumoniae
- Chlamydophila pneumoniae
Dosage Forms and Administration
Lefamulin is available in two dosage forms:
- Intravenous solution: 150 mg/15 mL
- Oral tablet: 600 mg
The typical dosage for adults with community-acquired bacterial pneumonia is:
- Intravenous (IV): 150 mg every 12 hours for 5 to 7 days.
- Oral: 600 mg every 12 hours for 5 days.
Patients can switch from IV to oral dosing to complete the course of therapy based on clinical response.
Side Effects and Warnings
Lefamulin may cause side effects, some of which can be serious. Common side effects include:
- Nausea, vomiting, and diarrhea
- Insomnia
- Low potassium levels
- Headache
- Abnormal liver function tests
- Injection site reactions (pain, bruising, swelling, or irritation)
Serious side effects requiring immediate medical attention include:
- Severe stomach pain and bloody or watery diarrhea
- Symptoms of low potassium such as leg cramps, constipation, irregular heartbeats, and muscle weakness
Precautions
Before taking lefamulin, patients should inform their doctor of any history of heart rhythm disorders, liver or kidney disease, and any medications they are currently taking. Lefamulin can interact with many drugs, leading to potentially dangerous effects. Pregnant women should use effective birth control during treatment and for at least 2 days after the last dose, as lefamulin may harm an unborn baby. Breastfeeding should be avoided within 2 days after using lefamulin, and any milk collected during this period should be discarded.
Administration Instructions
- Oral tablet: Take on an empty stomach, at least 1 hour before or 2 hours after a meal, with a full glass of water. Do not crush, chew, or break the tablet.
- Intravenous solution: Administered as an infusion into a vein over approximately 60 minutes. Proper mixing and storage of the injection are essential, and the mixture can be stored for up to 24 hours at room temperature or 48 hours in a refrigerator.
Conclusion
Lefamulin (Xenleta) is an FDA-approved antibiotic specifically indicated for the treatment of community-acquired bacterial pneumonia in adults. With its unique mechanism of action and broad-spectrum efficacy, it represents an important option in the management of bacterial pneumonia. Patients should adhere strictly to the prescribed dosage and be aware of potential side effects and interactions.
How to obtain the latest development progress of all drugs?
In the Synapse database, you can stay updated on the latest research and development advances of all drugs. This service is accessible anytime and anywhere, with updates available daily or weekly. Use the "Set Alert" function to stay informed. Click on the image below to embark on a brand new journey of drug discovery!
