Xenleta
Xenleta (lefamulin) is FDA approved to treat adults with community-acquired bacterial pneumonia (CABP). This medication is a type of antibiotic called a pleuromutilin antibiotic. Xenleta (lefamulin) is a tablet that's taken by mouth twice a day for 5 days. It's also available as an intravenous (IV) infusion that's given by a healthcare professional for 5 to 7 days. Side effects aren't common but can include diarrhea and nausea.
What is Xenleta (lefamulin)?
What is Xenleta (lefamulin) used for?
How Xenleta (lefamulin) works
Xenleta (lefamulin) is a pleuromutilin antibiotic. It works by stopping bacteria from making proteins that are important for them to grow and survive. This helps prevent bacteria from growing and helps fight the bacterial infection.
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What are the side effects of Xenleta (lefamulin)?
Common Side Effects
- Diarrhea (12%)
- Nausea (5%)
- Pain, swollen vein, or other reactions at the injection site (7%)
Other Side Effects
- Vomiting
- Higher liver enzyme levels
- Nausea
- Low potassium levels
- Trouble falling or staying asleep
- Headache
Serious Side Effects
- Abnormal heart rhythm (QT prolongation): chest pounding, chest pain, short of breath, feeling faint or lightheaded
- C. difficile-related diarrhea: rapid heart rate, fever, nausea, foul-smelling diarrhea, frequent bowel movements (even up to 15 times per day)
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- Severe diarrhea, fever
- Unusual vaginal discharge, itching, or odor
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Xenleta (lefamulin)
Pros
Available as a tablet and an IV infusion
Treatment typically lasts 5 to 7 days
Pharmacist tips for Xenleta (lefamulin)
Take Xenleta (lefamulin) either 1 hour before a meal or 2 hours after a meal. Swallow the tablets whole with 6 to 8 ounces of water.
Don't crush, chew, or cut the Xenleta (lefamulin) tablet. Contact your prescriber if you're having trouble swallowing the tablets to see whether there's a different antibiotic that you can take.
Take Xenleta (lefamulin) exactly as prescribed. Make sure to finish your treatment course, even if you're feeling better. Stopping the antibiotic earlier than prescribed can make your infection come back and become harder to treat.
Ask your prescriber if you should take a probiotic if you have diarrhea while you're taking Xenleta (lefamulin). Probiotics might help lessen this side effect. Be sure to take the probiotic at least 2 hours apart from Xenleta (lefamulin) to prevent Xenleta (lefamulin) from killing the "good" bacteria in the probiotic.
Get medical help right away if you start to have fever and watery or bloody diarrhea anytime while you're taking Xenleta (lefamulin) or after stopping the antibiotic. These might be signs of C. difficile-related diarrhea, which can be serious.
Let your care team know about all of your medications so they can check that your medications are safe to take together. Taking Xenleta (lefamulin) with certain medications can affect medications levels in your body. This can either make the medications work less well or raise your risk for side effects.
If you miss a dose of Xenleta (lefamulin), take it as soon as you remember, anytime up to 8 hours before the next dose. If your next dose is in less than 8 hours, skip the missed dose and take your next dose at the normal scheduled time. Don't take 2 doses to make up for the missed dose.
Frequently asked questions about Xenleta (lefamulin)
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What are the risks and warnings for Xenleta (lefamulin)?
Xenleta (lefamulin) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk for serious abnormal heart rhythm (QT prolongation)
Risk factors: 65 years and older | Low potassium or low magnesium levels | History of heart problems, slow heart rate, or other abnormal heart rhythms (arrhythmias) | Personal or family history of long QT syndrome | Taking medications that cause QT prolongation
Xenleta (lefamulin) can affect your heart rhythm, which can be serious and life-threatening. One example includes making the time it takes for your heart to pump and then relax longer. This is known as QT prolongation.
Your risk for QT prolongation is higher if you have certain factors, such as electrolyte problems or heart problems. The risk is also higher if you're taking other medications that cause heart rhythm problems, such as amiodarone (Pacerone) and ciprofloxacin (Cipro), among others. Call 911 right away if you feel your chest pounding, have shortness of breath or chest pain, or feel faint or lightheaded while you're taking Xenleta (lefamulin). These can be symptoms of heart rhythm problems.
Harm to an unborn baby
Xenleta (lefamulin) might cause harm to an unborn baby if it's taken during pregnancy. In animal studies, the antibiotic raised the number of pregnancy losses and stillbirths. These studies also found that the antibiotic affected the development of unborn animals.
Because of this risk, people who can become pregnant and are sexually active might need to take a pregnancy test before they can start Xenleta (lefamulin). They should also use a reliable birth control method while they're taking Xenleta (lefamulin) and and for 2 days after the last dose. Let your prescriber know if you think you might be pregnant before you start taking this medication.
Diarrhea from Clostridioides difficile infection
Xenleta (lefamulin) can raise your risk of getting infected with bacteria called Clostridioides difficile (C. diff). Antibiotics change the amount of normal bacteria in your stomach and intestines. This makes it easier for C. diff to overgrow in your gut and lead to an infection. This infection can cause severe and sometimes life-threatening diarrhea.
It's important to recognize the difference between diarrhea as a side effect of Xenleta (lefamulin) and C. diff-related diarrhea. This type of infectious diarrhea can cause rapid heart rate, fever, nausea, foul-smelling diarrhea, and frequent bowel movements (even up to 15 times per day). C. diff-related diarrhea is a medical emergency so get medical attention right away. You'll get tested for C. diff infection and get appropriate treatment if needed.
Drug-resistant bacteria
Take Xenleta (lefamulin) exactly as prescribed. Taking Xenleta (lefamulin) for any shorter or longer periods of time raise your risk for drug-resistant bacteria. The risk is also higher if you take the antibiotic to treat other illnesses besides community-acquired pneumonia. The chances of having a severe and life-threatening infection is higher if there's drug-resistant bacteria around in the body. Ask a member of your care team if you're not sure how you should be taking Xenleta (lefamulin).
Xenleta (lefamulin) dosage forms
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 600mg | 10 tablets | $1365.00 | $136.50 |
Typical dosing for Xenleta (lefamulin)
Xenleta (lefamulin) tablets: The typical dose is 600 mg by mouth every 12 hours for 5 days. Take the antibiotic on an empty stomach.
Xenleta (lefamulin) intravenous (IV) infusion: The typical dose is 150 mg infused through the vein every 12 hours for 5 to 7 days. The IV infusion is given by a healthcare professional. Your dose might differ if you have liver problems.
How much does Xenleta (lefamulin) cost?
Xenleta (lefamulin) contraindications
Take medications that interact with Xenleta (lefamulin) and raise the risk for heart rhythm problems (e.g., pimozide)
What are alternatives to Xenleta (lefamulin)?
Sudden worsening of chronic obstructive pulmonary disease (COPD) from a bacterial infection
Skin infections (e.g., cellulitis)
Urethra or cervix infections
Ear infections (ages 6 months and older)
Pneumonia (ages 6 months and older)
Strep throat (ages 2 years and older)
Tonsil infections (ages 2 years and older)
Upper respiratory tract infections (ear, nose, and throat infections)
Lower respiratory tract infections (e.g., pneumonia, bronchitis)
Skin infections (e.g., cellulitis)
Helicobacter pylori infection (adults only)
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References
Best studies we foundGilani, B., et al. (2023). Biochemistry, cytochrome P450. StatPearls.
Infectious Diseases Society of America. (n.d.). CAP clinical pathway.
Kozhokar, L., et al. (2022). Lefamulin. Hospital Pharmacy.
Nabriva Therapeutics US, Inc. (2024). Xenleta- lefamulin acetate injection, solution; Citric buffered normal saline- anhydrous citric acid injection, solution; Xenleta- lefamulin acetate tablet, coated [package insert]. DailyMed.
Paukner, S., et al. (2017). Pleuromutilins: Potent drugs for resistant bugs-mode of action and resistance. Cold Spring Harbor Perspectives in Medicine.
U.S. Food and Drug Administration. (2019). FDA approves new antibiotic to treat community-acquired bacterial pneumonia.
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