Lefamulin (le-FAM-ue-lin)

Treats community-acquired bacterial pneumonia (CABP). This medicine is a pleuromutilin antibiotic.

Brand Name(s):

Xenleta

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablet whole with water. Do not break, crush, or divide it.
• Take this medicine at least 1 hour before or 2 hours after a meal.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• Missed dose: If you miss a dose or forget to use your medicine, use it as soon as you can. If your next regular dose is less than 8 hours away, wait until then to use the medicine and skip the missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use lefamulin together with any of the following:
  • Erythromycin, moxifloxacin
  • Medicine to treat heart rhythm problems (including amiodarone, quinidine, procainamide, sotalol)
  • Medicine to treat mental illness (including pimozide)
  • Tricyclic antidepressants
• Some medicines may affect how lefamulin works. Tell your doctor if you are using alprazolam, diltiazem, ketoconazole, rifampin, simvastatin, vardenafil, or verapamil.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment and for at least 2 days after the last dose.
• Do not breastfeed during treatment and for at least 2 days after the last dose.
• Tell your doctor if you have kidney disease, liver disease, heart disease, or heart rhythm problem.
• This medicine may cause heart rhythm problem, including QT prolongation.
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine. It may occur 2 months or more after you stop using this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Diarrhea that may contain blood
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat

If you notice these less serious side effects, talk with your doctor:

• Mild diarrhea, nausea, vomiting

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088