Lefamulin (Intravenous)

Lefamulin injection 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 to be given only by or under the direct supervision of your doctor.

It is very important for your doctor to check your progress at regular visits to ensure 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 prevent 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®), medicines for heart rhythm problems (e.g., amiodarone, quinidine, procainamide, sotalol, Betapace®, Cordarone®), medicines for mental illness (e.g., pimozide, Orap®), or tricyclic antidepressants. Using these medicines together with lefamulin may cause serious unwanted side effects.

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

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

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

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it may provide. For this medicine, please consider the following:

Allergies

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

Pediatric

There have not been appropriate studies on the effects of lefamulin injection in children. Its safety and effectiveness have not been established in this age group.

Geriatric

So far, studies have not shown any specific problems in older adults that would limit the usefulness of lefamulin injection.

Breast Feeding

There are no adequate studies on how this medication affects infants when used by breastfeeding women. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if there may be interactions. In cases where two different medicines are used together, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the following medicines while receiving this medicine. The following interactions are based on their potential significance and are not an exhaustive list.

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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use 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 at the same time as food or specific types of food due to possible interactions. Also, using alcohol or tobacco with certain medicines may lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may impact how this medicine works. Be sure to inform your doctor if you have any other medical problems, especially:

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

• Severe liver disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical help.

Contact your doctor or nurse right away 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 happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to prevent or lessen some of these side effects. Talk to your health care professional if any of the following side effects continue, 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 happen in some patients. If you notice any other effects, consult with your healthcare professional.

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

In the U.S.

• Xenleta

Available Dosage Forms:

• Solution

Therapeutic Class: Antibiotic

Chemical Class: Pleuromutilin

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.