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Xenleta

lefamulin
Used for Pneumonia

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.

Reviewed by:Last reviewed on September 17, 2024
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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.

Drug facts

Common BrandsXenleta
Drug ClassPleuromutilin antibiotic
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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Side effects of Xenleta (lefamulin)

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.

Common Side Effects

Xenleta (lefamulin) tablets:

  • Diarrhea (12%)
  • Nausea (5%)

Xenleta (lefamulin) injection:

  • Pain, swollen vein, or other reactions at the injection site (7%)

Less Common Side Effects

Xenleta (lefamulin) tablets:

Xenleta (lefamulin) injection:

Xenleta (lefamulin) serious side effects

Contact your healthcare provider immediately if you experience any of the following.

  • 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 Xenleta (lefamulin) side effects have also been reported

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):

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Pros and cons of Xenleta (lefamulin)

Pros

  • Available as a tablet and an IV infusion
  • Treatment typically lasts 5 to 7 days

Cons

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Pharmacist tips for Xenleta (lefamulin)

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  • 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.
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Common questions about Xenleta (lefamulin)

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.

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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).

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Xenleta (lefamulin) dosage

The average cost for 30 tablets of 600mg of Xenleta (lefamulin) is $3,966.25 with a free GoodRx coupon. This is 28.75% off the average retail price of $5,566.45.
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600mg30 tablets$3,966.25$132.21

Typical dosage 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.
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Xenleta (lefamulin) contraindications

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.

  • Take medications that interact with Xenleta (lefamulin) and raise the risk for heart rhythm problems (e.g., pimozide)
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What are alternatives to Xenleta (lefamulin)?

There are a number of medications that your doctor can prescribe in place of Xenleta (lefamulin). Compare a few possible alternatives below.
Xenleta (lefamulin)
$3,966.25Lowest GoodRx priceView prices
Used for:

Adults

Azithromycin (Zithromax) can treat certain types of:

Children

Azithromycin (Zithromax) can treat certain types of:

  • 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)
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References

Best studies we found

Gilani, 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.

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