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.
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.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Xenleta (lefamulin) tablets:
Xenleta (lefamulin) injection:
Xenleta (lefamulin) tablets:
Xenleta (lefamulin) injection:
Contact your healthcare provider immediately if you experience any of the following.
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Based on clinical studies, your symptoms should start to improve within 3 to 5 days of starting Xenleta (lefamulin). The symptoms of pneumonia that the clinical study looked at were cough, the amount of phelgm you have, chest pain, and shortness of breath. Speak with your prescriber if you're not feeling better after several days of starting Xenleta (lefamulin). You might need to get tested for a fungal or viral infection, or you might simply just need a different antibiotic.
It takes about 2 days for most of Xenleta (lefamulin) to leave the body after one dose. This time frame is based on the medication's half-life, which is a measure of the time it takes to get rid of half the amount of medication from the body. Since the liver helps break down and get rid of the medication from the body, Xenleta (lefamulin) might stay longer in the body if you have liver problems.
Xenleta (lefamulin) is available as tablets that are taken by mouth on an empty stomach (at least 1 hour before a meal or 2 hours after a meal). Swallow tablets with a full glass (6 to 8 ounces) of water. Xenleta (lefamulin) also comes as an IV infusion that's typically used for people in the hospital who can't take the tablets. The antibiotic is infused through a vein over 1 hour.
Yes. It's important to share an updated medication list with your care team so they can check for drug interactions and adjust your treatment plan if needed. Certain medications can affect how much Xenleta (lefamulin) is in your body. Some medications, like verapamil and diltiazem, can raise the amount of Xenleta (lefamulin) in your body and raise the risk for side effects from the antibiotic. Other medications, such as carbamazepine (Tegretol) and other seizure medications, can lower the amount of Xenleta (lefamulin) and make the antibiotic work less well to treat your infection. Also, it's recommended to avoid medications that cause QT prolongation (a heart rhythm problem), like antipsychotics and certain antidepressants, because taking these medications with Xenleta (lefamulin) can put you at even higher risk for the heart rhythm problem.
No, Xenleta (lefamulin) isn't a fluoroquinolone antibiotic. Instead, it's a newer type of antibiotic called pleuromutilin antibiotic. Fluoroquinolones and pleuromutilins work differently to kill bacteria. Fluoroquinolones stop bacteria from making their own genetic material (e.g., DNA), whereas pleuromutilins stop bacteria from making proteins they need to grow and survive. Fluoroquinolones are an older class of antibiotics that can be used for many different types of infections, whereas Xenleta (lefamulin) is only used for community-acquired pneumonia.
Xenleta (lefamulin) isn't recommended during pregnancy because it can potentially cause harm to your baby. As a precaution, people who can get pregnant should use a reliable form of birth control during treatment and for 2 days after the last dose if they're sexually active. If you accidentally take Xenleta (lefamulin) while pregnant, it's encouraged that you enroll in the manufacturer's surveillance program to help researchers learn more about the safety risks to you and your unborn baby. You can enroll in the program by calling 1-855-5NABRIVA.
It's not recommended that you breastfeed while you're taking Xenleta (lefamulin) and for 2 days after your last dose. It's not known whether the antibiotic can get into breast milk. But there's a possibility of serious side effects in your baby, such as heart rhythm problems (QT prolongation). The manufacturer recommends to pump and dump your breast milk while you're taking Xenleta (lefamulin) and for 2 days after your last dose. You can also ask a healthcare professional about other alternatives.
The FDA approved Xenleta (lefamulin) in August 2019. It's approved for treating community-acquired bacterial pneumonia (CABP) in adults.
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.
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.
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.
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.
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).
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 600mg | 30 tablets | $3,966.25 | $132.21 |
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Xenleta (lefamulin) will not be safe for you to take.
Adults
Azithromycin (Zithromax) can treat certain types of:
Children
Azithromycin (Zithromax) can treat certain types of: