(le fam' ue lin)

Brand Name(s): Xenleta^®

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.

Are there OTHER USES for this medicine?

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

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.

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.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antipsychotic medications (medications to treat mental illness); amiodarone (Nexterone, Pacerone); erythromycin (E.E.S., Eryc, Erythrocin); moxifloxacin (Avelox); procainamide, pimozide (Orap), quinidine (in Nuedexta); rifampin (Rifadin, Rimactane, in Rifamate, Rifater); and tricyclic antidepressants such as amitriptyline, desipramine (Norpramin), clomipramine (Anafranil), imipramine (Tofranil), nortriptyline, or trimipramine (Surmontil); Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with lefamulin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• 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?

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

• nausea
• headache
• difficulty falling asleep or staying asleep
• swelling, pain, or redness near the spot where the medication was injected

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 (http://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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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.