Pronunciation:

le-FAM-ue-lin

Brand Names:

• Xenleta

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antibiotic

Chemical—

Pleuromutilin

Uses of This Medicine:

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

Lefamulin belongs to the class of medicines known as pleuromutilin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lefamulin injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lefamulin injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 medication 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 usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the 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
• 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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or
• Heart rhythm problems (eg, QT prolongation, ventricular arrhythmia)—Use with caution. May make these conditions worse.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to remain in place for at least 1 hour. It is usually given every 12 hours for 5 to 7 days.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed 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 keep from getting pregnant during treatment and for at least 2 days after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Do not use this medicine if you are also using erythromycin (Ery-Tab®), moxifloxacin (Avelox®), medicine to treat heart rhythm problems (eg, amiodarone, quinidine, procainamide, sotalol, Betapace®, Cordarone®), medicine to treat mental illness (eg, pimozide, Orap®), or tricyclic antidepressants. Using these medicines together with lefamulin may cause unwanted serious side effects.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have 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 such as QT prolongation.

Lefamulin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without checking first with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

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

Side Effects of This Medicine:

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

Check with your doctor or nurse 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 or are bothersome or if you have any questions about them:

More common

Pain, itching, burning, swelling, or a lump at the injection site

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.