Lefamulin Injection

WHY is this medicine prescribed?

Lefamulin injection 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 injection 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 injection will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

HOW should this medicine be used?

Lefamulin injection comes as a solution to be injected intravenously (into a vein) over a period of 60 minutes. It is usually given every 12 hours for 5 to 7 days.

You may receive lefamulin injection in a hospital, or you may administer the medication at home. If you will be using lefamulin injection at home, your healthcare provider will show you how to use the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. Ask your healthcare provider what to do if you have any problems injecting lefamulin injection.

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

Use lefamulin injection until you finish the course of treatment, even if you feel better. If you stop using lefamulin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

Before using lefamulin injection,

• tell your doctor and pharmacist if you are allergic to lefamulin, retapamulin (Altabax), any other medications, or any of the ingredients in lefamulin injection. Ask your pharmacist for a list of the ingredients.
• some medications should not be taken with lefamulin injection. Other medications may cause dosing changes or extra monitoring when taken with lefamulin injection. Make sure you have discussed any medications you are currently taking or plan to take before receiving lefamulin injection with your doctor and pharmacist. Before starting, stopping, or changing any medications while receiving lefamulin injection, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with lefamulin injection: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start receiving lefamulin injection. Do not start this medication while receiving lefamulin injection 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 receiving 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.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

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 injection may cause other side effects. Call your doctor if you have any unusual problems while receiving 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).

What should I know about STORAGE and DISPOSAL of this medication?

Your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly.

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.

What should I do in case of OVERDOSE?

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.

Symptoms of overdose may include the following:

• seizures
• confusion
• muscle jerks, shakes, or spasms

What OTHER INFORMATION should I know?

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.

Brand Name(s):

• Xenleta®

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: December 15, 2019.