Lefamulin injection

What is this medication?

LEFAMULIN (lef a MUE lin) is a pleuromutilin antibiotic. It is used to treat certain kinds of bacterial infections. It will not work for colds, flu, or other viral infections.

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 antibiotics or medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is usually given by a healthcare professional in a hospital or clinic setting.

In rare cases, you might get this medicine at home. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

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 healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine 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 it important not to miss your dose. Call your doctor or healthcare professional if you are unable to keep an appointment. If you give yourself the medicine and 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.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• pimozide
• thioridazine

This medicine may also interact with the following medications:

• alprazolam
• birth control pills
• diltiazem
• ketoconazole
• other medicines that prolong the QT interval (cause an abnormal heart rhythm)
• 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 medicine. Tell your healthcare professional 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 healthcare professional if you have diarrhea that lasts more than 2 days or if it is severe and watery.

This medicine may stay in your body for up to 2 days after your last dose. Tell your healthcare professional about any unusual symptoms. If you're a woman, do not get pregnant for at least 2 days after your last dose. If you do get pregnant, tell your healthcare professional.

Birth control may not work properly while you are taking this medicine. Talk to your healthcare professional about using an extra method of birth control.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or hives, swelling of the face, lips, or tongue
• bloody or watery diarrhea
• fever
• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast, irregular heartbeat; palpitations; feeling faint or lightheaded; falls; breathing problems
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs and symptoms of low potassium like muscle cramps; muscle pain; chest pain; dizziness; feeling faint or lightheaded, falls; palpitations; breathing problems; or fast, irregular heartbeat

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

• diarrhea
• headache
• nausea, vomiting
• pain, redness, or irritation at site where injected
• 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.

If you are using this medicine at home, you will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.

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.