Xenleta (Lefamulin) – Oral

What Is Xenleta?

Xenleta (lefamulin) is a prescription antibiotic drug used to treat adults with community-acquired bacterial pneumonia (CABP). CABP means that you were infected with bacterial pneumonia in a community setting rather than a hospital or other healthcare facility.

Xenleta is in a drug class called pleuromutilin antibiotics. It works by slowing the growth of bacteria or killing bacteria.

Xenleta is available as an oral tablet that is taken by mouth. It is also available as an injection, given as an intravenous infusion (into a vein). This article will focus on the oral form of Xenleta.

What Is Xenleta Used For?

The Food and Drug Administration (FDA) approved Xenleta to treat adults with CABP caused by the following bacteria:

• Streptococcus pneumoniae
• Staphylococcus aureus (methicillin-susceptible)
• Haemophilus influenzae
• Legionella pneumophila
• Mycoplasma pneumoniae
• Chlamydophila pneumoniae

Xenleta should only be used to treat or prevent infections that are proven or strongly suspected to be caused by one of the bacteria listed above. Xenleta cannot be used to treat a viral infection, such as the common cold or flu.

How to Take Xenleta

Read the patient information leaflet that comes with your prescription. Ask your healthcare provider if you have any questions or concerns before starting treatment.

Follow these instructions when taking Xenleta:

• Take Xenleta by mouth on an empty stomach, this means at least one hour before eating or two hours after eating. 
• Take Xenleta with a full glass of water (6–8 ounces).
• Swallow the tablet whole. Do not crush, chew, or break the tablet.
• Take Xenleta for the full length of treatment. Do not skip doses or stop taking Xenleta early, even if you feel better. This can increase the risk of having an infection that does not respond to antibiotics. 

Your provider may order tests to check your liver function while you take Xenleta. 

Storage

Store Xenleta at room temperature (about 68–77 degrees Fahrenheit), away from heat, direct light, and moisture. Do not store it in the bathroom. Keep the medication in its original labeled container and out of the reach (and out of sight) of children and pets. Keep the bottle tightly closed when not in use.

What Are the Side Effects of Xenleta?

This is not a complete list of side effects and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

The most common side effects of Xenleta are:

• Stomach problems, including nausea, vomiting, diarrhea
• Insomnia
• Headache
• Low potassium levels: Call your provider right away if you have any of the following symptoms: leg cramps, constipation, irregular heartbeat, fluttering in the chest, increased thirst or urination, numbness/tingling, muscle weakness, limp feeling.
• Elevated liver enzymes

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Hypersensitivity reaction or anaphylaxis: Symptoms can include rash, hives, swelling around the lips, tongue, throat, and face, and trouble breathing. These symptoms require emergency medical attention. 
• Clostridioides difficile (C. difficile)–associated diarrhea: Symptoms include severe, watery/bloody diarrhea, and stomach pain/cramping, which can occur up to two months after you finish taking the antibiotic. Call your provider right away if symptoms occur.
• Low platelet levels
• Low red blood cells
• QT prolongation: This is a serious heart rhythm disorder that may cause fast, chaotic heartbeats.
• Atrial fibrillation: A-fib is an irregular (and often fast) heartbeat that can lead to complications like blood clots, stroke, or heart failure.

Long-Term Side Effects

While Xenleta is well-tolerated, delayed side effects are possible. One side effect that can happen with any antibiotic is C. difficile–associated diarrhea. Symptoms may include watery, bloody diarrhea and stomach pain. It can appear up to two months after you finish the antibiotic. If these symptoms occur, notify your healthcare provider right away.

Dosage: How Much Xenleta Should I Take?

Modifications

There are various situations in which you might need to adjust your treatment regimen.

Pregnancy

Xenleta can harm the fetus if taken during pregnancy. Tell your provider if you are pregnant or think you may become pregnant. Avoid becoming pregnant while taking Xenleta.

If you are of childbearing age, use effective birth control while taking Xenelta for two days after the final dose. Nabriva Therapeutics, the manufacturer of Xenleta, has a surveillance program for people who have taken Xenleta inadvertently while pregnant. Call 855-5NABRIVA to enroll in the program.

Breastfeeding

Xenleta may be present in breast milk. Pump and discard milk while taking Xenleta and for two days after the last dose of Xenleta.

Liver Problems

People with moderate to severe liver problems should not take Xenleta.

Missed Dose

If you miss a dose of Xenleta, take it as soon as you remember. If the next dose is due in less than eight hours, skip the dose and continue with your regular schedule. Do not double up on doses to make up for a missed dose. Consult your healthcare provider if you have questions about a missed dose.

Overdose: What Happens If I Take Too Much Xenleta?

Do not take more Xenleta than prescribed. If you think you’ve taken too much, contact your healthcare provider for next steps.

Precautions

What Are Reasons I Shouldn’t Take Xenleta?

Xenleta is not appropriate for everyone. 

You should not take Xenleta if you are:

• Allergic to lefamulin or any of the inactive ingredients in Xenleta
• Are pregnant
• Have QT prolongation, ventricular arrhythmia, or a history of torsades de pointes (a type of fast heart rhythm that begins in the ventricles)

Xenleta may be prescribed with caution in some people, only if the healthcare provider determines it is safe. This includes people who:

• Have electrolyte abnormalities
• Have congenital long QT syndrome (born with long QT syndrome)
• Have bradycardia (a slow heart rate)
• Have had a recent heart attack 
• Have congestive heart failure (CHF)
• Are a woman of childbearing age
• Are on dialysis
• Have kidney failure 
• Have liver problems
• Have a recent history of antibiotic-associated diarrhea/colitis
• Have a family history of QT prolongation

What Other Medications Interact With Xenleta?

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, and vitamins or supplements. Many drugs can interact with Xenleta. Do not start or stop any medicines while taking Xenleta unless your provider approves. 

Some drugs can affect blood levels of other drugs, which can either increase side effects or make the medications less effective.

Xenleta can cause a serious heart problem and some drug interactions can increase the risk of heart problems.

Medications that may interact with Xenleta include:

• Avelox (moxifloxacin)
• Betapace (sotalol)
• Calan (verapamil)
• Cardizem (diltiazem)
• Cordarone (amiodarone)
• Erythromycin 
• Levitra (vardenafil)
• Orap (pimozide)
• Procanbid (procainamide)
• Prograf (tacrolimus)
• Quinalan or Cardioquin (quinidine) 
• Seroquel (quetiapine)
• Tricyclic antidepressants such as Elavil (amitriptyline) or Pamelor (nortriptyline)
• Xanax (alprazolam)
• Zocor (simvastatin)

This is not a full list of drug interactions. Other drug interactions may occur with Xenleta. Consult your healthcare provider for a full list of drug interactions.

What Medications Are Similar?

Xenleta is a pleuromutilin antibiotis used for CABP. The other drug in this class is called Altabax (retapamulin). Altabax is a topical ointment that is used to treat impetigo, a contagious skin infection. 

Other antibiotics in different drug classes that are used to treat CABP include:

• Macrolide antibiotics, such as Biaxin (clarithromycin) or Zithromax (azithromycin)
• Quinolone (fluoroquinolone) antibiotics, such as Cipro (ciprofloxacin) or Levaquin (levofloxacin)
• Vibramycin (doxycycline)

This is a list of drugs also prescribed for CABP. It is not a list of drugs recommended to take with Xenleta. Ask your pharmacist or a healthcare practitioner if you have questions.

How Can I Stay Healthy While Taking Xenleta?

Before taking Xenleta, discuss your medical history and all medication you take with your healthcare provider. 

When taking Xenleta, follow your healthcare provider’s instructions for use. Read the patient information leaflet that comes with your prescription and ask your provider if you have any questions.

Once you start taking Xenleta, you may start to feel better after a few days of treatment. However, some symptoms may linger for a longer time. Be sure to finish the full course of treatment as prescribed by your healthcare provider.

While you are recovering from CABP:

• Get plenty of rest (this includes naps during the day).
• Drink lots of fluids, such as water and juice, to avoid dehydration. Avoid alcohol.
• Use a warm water humidifier as needed.
• Place a warm wet washcloth loosely over the nose and mouth as needed to help loosen mucus.
• Try to take a few deep breaths several times every hour to help open up the lungs.
• Tap your chest gently several times a day while lying with your head lower than the chest, to help bring up mucus so you can cough it out.  
• Ask your healthcare provider before taking any cough or cold medication. 

Follow up with your healthcare provider as planned. Let your provider know if symptoms worsen or do not improve.