Lefamulin

Lefamulin is used to treat community acquired pneumonia (a lung infection that developed in a person who was not in the hospital) caused by certain types of bacteria. Lefamulin is in a class of medications called pleuromutilin antibiotics. It works by slowing the growth or killing bacteria that cause infections.

Antibiotics such as lefamulin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Lefamulin comes as a tablet to take by mouth. It is usually taken every 12 hours on an empty stomach (at least 1 hour before or 2 hours after a meal) for 5 days or for the remaining days of treatment after receiving this medication intravenously (into a vein). Take lefamulin at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lefamulin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole with a glass (6 to 8 oz) of water; do not split, chew, or crush them.

You should begin to feel better during the first few days of treatment with lefamulin. If your symptoms do not improve or get worse, call your doctor.

Take lefamulin until you finish the prescription, even if you feel better. If you stop taking lefamulin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking lefamulin,

• tell your doctor and pharmacist if you are allergic to lefamulin, retapamulin (Altabax), any other medications, or any of the ingredients in lefamulin tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you are taking pimozide (Orap). Your doctor will probably tell you not to take lefamulin if you are taking this medication.
• some medications should not be taken with lefamulin. Other medications may cause dosing changes or extra monitoring when taken with lefamulin. Make sure you have discussed any medications you are currently taking or plan to take before starting lefamulin with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking lefamulin, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with lefamulin: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking lefamulin. Do not start this medication while taking lefamulin without discussing with your healthcare provider.
• tell your doctor if you have or have ever had prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), other types of an irregular heartbeat, or liver disease. Also tell your doctor if you have kidney disease and are receiving dialysis treatments.
• tell your doctor if you are pregnant, or plan to become pregnant. You will need to have a negative pregnancy test before beginning treatment with lefamulin. Use birth control during your treatment and for 2 days after your final dose. If you become pregnant while taking lefamulin, call your doctor immediately.
• tell your doctor if you are breastfeeding. Your doctor may tell you not to breastfeed during your treatment, and for 2 days after your final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking lefamulin.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if the next dose is due in less than 8 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Lefamulin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:

• severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)

Lefamulin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Xenleta^®