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Xenleta (Generic Lefamulin)

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Why is this medication prescribed?

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.

How should this medicine be used?

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.

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 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.
  • 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: alprazolam (Xanax); antipsychotic medications (medications to treat mental illness); amiodarone (Nexterone, Pacerone); diltiazem (Cardizem, Tiazac, others); erythromycin (E.E.S., Eryc, Erythrocin); ketoconazole; moxifloxacin (Avelox); procainamide,quinidine (in Nuedexta); rifampin (Rifadin, Rimactane, in Rifamate, Rifater); simvastatin (Flolopid, Zocor, in Vytorin); sotalol (Betapace, Sorine); tricyclic antidepressants such as amitriptyline, desipramine (Norpramin), clomipramine (Anafranil), imipramine (Tofranil), nortriptyline, or trimipramine (Surmontil); vardenafil (Levitra, Staxyn); and verapamil (Calan, Verelan, in Tarka). 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 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.

What special dietary instructions should I follow?

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

What should I do if I forget a dose?

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.

What side effects can this medication cause?

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

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).

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.

In case of emergency/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.

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.

Brand names

  • Xenleta®
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