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Xenleta is used to treat pneumonia caused by certain bacteria. It stops certain types of bacteria from making proteins they need to grow and multiply. Nausea is a common side effect. If you get severe or persistent diarrhea even up to two months after stopping Xenleta, call your health care provider right away. Tell your health care provider about all medicines and supplements that you take before using Xenleta.

Uses

What is Xenleta used for?

Xenleta (lefamulin) is commonly used to treat pneumonia caused by certain bacteria.

Xenleta may also be used for other conditions as determined by your health care provider.

Xenleta may not be right for some types of pneumonia, depending on which germs are causing the infection. Bacteria may have developed resistance to Xenleta, which will make it not work as well.

How does Xenleta work (mechanism of action)?

Xenleta stops certain types of bacteria from making proteins they need to grow and multiply.

How is Xenleta supplied (dosage forms)?

Brands and other names

  • Xenleta

Dosage forms and strengths

  • 600 mg oral tablet

Xenleta is also available in an injectable form that is given by a health care provider.

How should I store Xenleta?

Oral Tablet. Xenleta tablets should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). They can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting them. Store in a cool, dry place.

Injection Liquid. Xenleta injection is usually given by a health care provider in a hospital or clinic. If you will store Xenleta injection at home, follow the instructions given by your health care provider.

Side Effects

What are the most common side effects of Xenleta?

The most common side effects of Xenleta are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Diarrhea
  • Nausea and vomiting
  • Abnormal liver function tests
  • Reaction at the site of injection (injection)
  • Low potassium level (injection)
  • Trouble sleeping (injection)
  • Headache (injection)

There may be other side effects of Xenleta that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Xenleta?

While less common, the most serious side effects of Xenleta are described below, along with what to do if they happen.

Severe Allergic Reactions. Xenleta may cause allergic reactions, which can be serious. Stop using Xenleta and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Heart Rhythm Changes. Xenleta may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint or notice changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Antibiotic-Associated Diarrhea. An overgrowth of germs called Clostridioides difficile, or “C. diff,” can happen in your gut with many types of antibiotics, including Xenleta. This can cause a condition known as antibiotic-associated diarrhea, which can happen even up to two months after stopping the antibiotic. Call your health care provider right away if you have any of the following symptoms of this condition.

  • Watery diarrhea
  • Diarrhea that does not go away
  • Blood in your stool (poop)
  • Severe stomach cramps
  • Fever that starts after you start or finish the medicine

Warnings & Precautions

Who should not use Xenleta?

Allergies to Ingredients. People who are allergic to any of the following should not use Xenleta.

  • Lefamulin
  • Xenleta
  • Any other medicine known as a pleuromutilin antibiotic
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Xenleta.

Drug Interactions. Xenleta should not be used while you are using certain other medicines. Before using Xenleta, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.  See the Interactions section for more details.

What should I know about Xenleta before using it?

Do not use Xenleta unless it has been prescribed to you by a health care provider. Use it as prescribed.

Do not share Xenleta with other people, even if they have the same condition as you. It may harm them.

Keep Xenleta tablets out of the reach of children. Xenleta injection is usually given by a health care provider in a hospital or clinic. 

Swallow Xenleta tablets whole with 6-8 oz of water. Do not crush or divide the tablets.

What should I tell my health care provider before using Xenleta?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Xenleta is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems
  • Heart rhythm problems
  • Long QT syndrome

Pregnancy. Xenleta may cause harm to a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Use effective birth control during your use of Xenleta and for two days after your final dose. If you become pregnant, stop using Xenleta right away and contact your health care provider.  People who have taken Xenleta while pregnant can enroll in a surveillance program by calling 855-5NABRIVA.

Breastfeeding. It is not known if Xenleta passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should stop breastfeeding or stop Xenleta.

How can I get more information about Xenleta?

For more information about Xenleta, you can visit the drugmaker’s website at www.nabriva.com or call them at  610-816-6640.

Interactions

Does Xenleta interact with foods or drinks?

Take Xenleta tablets at least one hour before a meal or two hours after a meal. There are no known interactions between Xenleta injection and foods or drinks.

It is unknown if drinking alcohol will affect Xenleta, but heavy drinking can slow your immune response and make it harder for your body to fight infection.

Does Xenleta interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before using Xenleta.

  • A medicine used to control your heart rate or rhythm (antiarrhythmic), including amiodarone, procainamide, quinidine, and sotalol
  • An antipsychotic, which is a medicine for certain mental health conditions
  • Erythromycin (Ery-Tab and others) or moxifloxacin, which are medicines used for bacterial infections
  • A tricyclic antidepressant, such as amitriptyline, nortriptyline, or protriptyline, even if it is not used for depression
  • Pimozide, which is a medicine used for Tourette’s syndrome
  • Any other medicine that can cause QT prolongation, which is a potentially dangerous heart rhythm problem

Many other medicines may alter the blood levels of Xenleta, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Xenleta. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Xenleta?

If you or someone else has used too much Xenleta, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Xenleta?

If you miss a dose of Xenleta tablet and there are at least eight hours remaining until the next scheduled dose, take the missed dose as soon as possible. If there are less than eight hours remaining before the next scheduled dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

Xenleta injection is usually given by a health care provider in a hospital. Your health care provider will make sure you are receiving Xenleta injection as scheduled. If you miss an appointment to get your Xenleta injection dose, call to make another appointment as soon as possible. 

It is important to complete your prescribed course of Xenleta, even if your symptoms get better or go away. This will reduce the risk that future infections are resistant to Xenleta or other similar medicines.