Lefamulin (Oral)

Lefamulin is used to treat community-acquired bacterial pneumonia (CABP).

Lefamulin belongs to a group of medicines called pleuromutilin antibiotics. It works by killing bacteria or stopping them from growing. However, this medicine will not work for colds, flu, or other viral infections.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress during regular visits to ensure that this medicine is working properly. You may need blood and urine tests to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy during treatment and for at least 2 days after the last dose. If you think you may be pregnant while using this medicine, tell your doctor immediately.

Do not use this medicine if you are also taking erythromycin (Ery-Tab®), moxifloxacin (Avelox®), any medicine for heart rhythm problems (such as amiodarone, quinidine, procainamide, sotalol, Betapace®, Cordarone®), any medicine for mental illness (such as pimozide, Orap®), or tricyclic antidepressants. Taking these medicines with lefamulin may cause serious unwanted side effects.

Contact your doctor right away if you notice any changes in your heart rhythm. You may feel dizzy or faint, or you may experience a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem like QT prolongation.

Lefamulin may cause diarrhea, which can be severe in some cases. It can occur 2 months or more after you stop taking this medicine. Do not take any medicine for diarrhea without checking with your doctor first. Diarrhea medicines may worsen the diarrhea or make it last longer. If you have any questions about this or if mild diarrhea continues or worsens, consult your doctor.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you need to consider the risks of taking it versus the benefits it may provide. This decision is made with your doctor. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or other medicines. Also, let your healthcare provider know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been any appropriate studies on how age affects the use of lefamulin in children. Its safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems for older adults that would limit the use of lefamulin.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. If you are taking this medicine, it is very important that your healthcare provider knows if you are taking any of the medicines listed below. The following interactions are highlighted due to their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medicine or change some of the other medicines you take.

• Dasatinib
• Dofetilide
• Dronedarone
• Ivabradine
• Levoketoconazole
• Pimavanserin
• Pimozide
• Quetiapine
• Quinidine
• Tacrolimus
• Vardenafil

Using this medicine with any of the following medicines is generally not recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Acalabrutinib
• Acecainide
• Adagrasib
• Alfentanil
• Alfuzosin
• Amiodarone
• Amitriptyline
• Anagrelide
• Apalutamide
• Apomorphine
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Avanafil
• Azithromycin
• Bedaquiline
• Bepridil
• Boceprevir
• Bosentan
• Bosutinib
• Bretylium
• Budesonide
• Buprenorphine
• Buserelin
• Buspirone
• Carbamazepine
• Carvedilol
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Cisapride
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cobicistat
• Cobimetinib
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dabrafenib
• Darifenacin
• Darunavir
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexmedetomidine
• Dihydroergotamine
• Disopyramide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Eletriptan
• Encorafenib
• Enzalutamide
• Eplerenone
• Ergotamine
• Eribulin
• Erythromycin
• Escitalopram
• Etrasimod
• Etravirine
• Everolimus
• Famotidine
• Felbamate
• Felodipine
• Fentanyl
• Fexinidazole
• Fingolimod
• Flecainide
• Flibanserin
• Fluconazole
• Fluoxetine
• Fluticasone
• Formoterol
• Fosaprepitant
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibrutinib
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Itraconazole
• Ivacaftor
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lomitapide
• Lopinavir
• Lorlatinib
• Lovastatin
• Lumacaftor
• Lumefantrine
• Lurasidone
• Macimorelin
• Maraviroc
• Mefloquine
• Mesoridazine
• Methadone
• Methotrimeprazine
• Metronidazole
• Midazolam
• Mifepristone
• Mitotane
• Mizolastine
• Mobocertinib
• Modafinil
• Moricizine
• Moxifloxacin
• Nafarelin
• Nafcillin
• Naloxegol
• Nefazodone
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osimertinib
• Oxycodone
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pipamperone
• Piperaquine
• Pitolisant
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Rifabutin
• Rifampin
• Risperidone
• Ritonavir
• Saquinavir
• Sertindole
• Sertraline
• Sevoflurane
• Sildenafil
• Simvastatin
• Sirolimus
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sparfloxacin
• St John's Wort
• Sulpiride
• Sultopride
• Sunitinib
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Temsirolimus
• Terfenadine
• Tetrabenazine
• Thioridazine
• Ticagrelor
• Tipranavir
• Tolterodine
• Tolvaptan
• Toremifene
• Trazodone
• Triazolam
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vemurafenib
• Venetoclax
• Venlafaxine
• Verapamil
• Vernakalant
• Vilanterol
• Vinflunine
• Voriconazole
• Vorinostat
• Ziprasidone
• Zotepine
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating or with certain foods as interactions may happen. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare provider about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Diarrhea or
• Heart rhythm problems (e.g., QT prolongation, ventricular arrhythmia)—Use with caution. This may worsen these conditions.

• Liver disease, moderate to severe—Use is not recommended in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do happen, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Convulsions
• decreased urine
• dry mouth
• increased thirst
• irregular heartbeat
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• trouble breathing
• unusual tiredness or weakness

Incidence not known

• Abdominal or stomach tenderness
• chest pain or discomfort
• fainting
• fever
• irregular or slow heart rate
• severe abdominal or stomach cramps and pain
• watery and severe diarrhea, which may also be bloody

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Headache
• trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Xenleta

Available Dosage Forms:

• Tablet

Therapeutic Class: Antibiotic

Chemical Class: Pleuromutilin

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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.

Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your infection may not clear up.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For community-acquired bacterial pneumonia: Adults—600 milligrams (mg) every 12 hours, to be taken for 5 days. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If your next regular dose is less than 8 hours away, wait until then to use the medicine and skip the missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.