Lefamulin Injection

What is this medication?

LEFAMULIN (lef a MUE lin) treats infections caused by bacteria. It belongs to a group of medications called antibiotics. It will not treat colds, the flu, or infections caused by viruses.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Xenleta Solution

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• History of irregular heartbeat
• Kidney disease
• Liver disease
• An unusual or allergic reaction to lefamulin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is infused into a vein. It is usually given by your care team in a hospital or clinic setting. It may also be given at home.

If you get this medication at home, you will be taught how to prepare and give it. Use exactly as directed. Take it as directed on the prescription label at the same time every day. Take all of this medication unless your care team tells you to stop it early. Keep taking it even if you think you are better.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or care team to get one.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you get this medication at the hospital or clinic: It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

If you give yourself this medication at home: If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your care team with questions.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Alprazolam
• Diltiazem
• Estrogen or progestin hormones
• Ketoconazole
• Other medications that cause heart rhythm changes
• Rifampin
• Simvastatin
• Vardenafil
• Verapamil

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. Tell your care team if your symptoms do not start to get better or if they get worse.

Do not treat diarrhea with over the counter products. Contact your care team if you have diarrhea that lasts more than 2 days or if it is severe and watery.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication may cause serious birth defects if taken during pregnancy and for 2 days after stopping therapy. Estrogen and progestin hormones may not work as well while you are taking this medication. A barrier contraceptive, such as a condom or diaphragm, is recommended. Talk to your care team about other forms of contraception.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Severe diarrhea, fever
• Unusual vaginal discharge, itching, or odor

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Headache
• Nausea
• Pain, redness, or irritation at injection site
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

You will be instructed on how to store this medication. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.