Xenleta

Xenleta is a prescription medication used to treat community-acquired bacterial pneumonia (a lung infection that developed in a person who was not in the hospital) caused by certain microorganisms.

Xenleta belongs to a group of drugs called systemic pleuromutilin antibacterials. Xenleta works by inhibiting bacterial protein synthesis which causes bacterial cell death.

This medication comes in two forms: a tablet form to be taken by mouth and an injectable form to be given directly into a vein (IV). Xenleta tablets should be taken on an empty stomach and should be swallowed whole with a full glass of water. Xenleta should not be crushed or divided.

Common side effects include diarrhea, nausea, vomiting, and liver enzyme elevation.

Xenleta is a prescription medication used for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

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

Serious side effects may occur. See "Xenleta Precautions" section.

The most common side effects of Xenleta Injection are administration site reactions, liver enzyme elevation, nausea, low blood potassium levels (hypokalemia), insomnia, and headache.

The most common side effects of Xenleta Tablets are diarrhea, nausea, vomiting, and liver enzyme elevation.

These are not all the possible side effects of Xenleta.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1- 800-FDA-1088.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Xenleta may affect the way other medicines work and other medicines may affect how Xenleta works.

Especially tell your healthcare provider if you take:

• pimozide
• ritonavir
• atazanavir
• darunavir
• indinavir
• lopinavir
• nelfinavir
• saquinavir
• tipranavir
• ketoconazole
• itraconazole
• nefazodone
• rifampicin
• carbamazepine
• phenytoin
• St John’s Wort
• clarithromycin
• telithromycin
• erythromycin
• amiodarone
• moxifloxacin
• procainamide
• quinidine
• amitriptyline
• desipramine
• clomipramine 
• imipramine
• nortriptyline
• trimipramine
• alprazolam
• simvastatin
• sotalol
• verapamil
• vardenafil
• diltiazem

You should not start or stop any medicine before you talk with the healthcare provider that prescribed Xenleta.

Know the medicines you take. Keep a list of them with you to show to your healthcare provider and pharmacist when you get a new medicine.

This is not a complete list of Xenleta drug interactions. Ask your doctor or pharmacist for more information.

Xenleta may cause a heart rhythm disorder that can cause serious irregular heart rhythms (arrhythmias). This condition is known as QT prolongation. Before receiving Xenleta, 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.

Based on animal studies, Xenleta may cause fetal harm. You will need to have a negative pregnancy test before beginning Xenleta treatment. Use birth control during your treatment and for 2 days after your final dose. If you become pregnant while receiving Xenleta, call your doctor immediately.

Severe diarrhea (watery or bloody stools) may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment). Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibiotics, including Xenleta, with severity ranging from mild diarrhea to fatal colitis. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Xenleta, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Xenleta, tell your healthcare provider about all your medical conditions, including if you:

• are allergic to Xenleta, any other medications, or any of the ingredients in this medication.
• 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.
• are pregnant, or plan to become pregnant. 
• tell your doctor if you are breastfeeding or planning to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

You will need to have a negative pregnancy test before beginning Xenleta treatment. Use birth control during your treatment and for 2 days after your final dose. If you become pregnant while receiving Xenleta, call your doctor immediately.

Tell your healthcare provider if you are breastfeeding or planning to breastfeed.

Do not breastfeed during treatment and for at least 2 days after your final dose. Lactating women should pump and discard milk for the duration of treatment with Xenleta and for 2 days after the final dose.

Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Xenleta exactly as directed.

Do not take more or less of it or take it more often than prescribed by your doctor.

Xenleta Tablets

• Xenleta 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 Xenleta at around the same time(s) every day.
• Swallow the tablets whole with a glass (6 to 8 oz) of water; do not split, chew, or crush them.

Xenleta Injection

• Xenleta 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 Xenleta injection in a hospital, or you may administer the medication at home. If you will be using Xenleta 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 administering this medication.

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

Take Xenleta until you finish the prescription, even if you feel better. If you stop taking Xenleta too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dosage of Xenleta is:

• 150 mg every 12 hours by intravenous infusion over 60 minutes for 5 to 7 days, with the option to switch to Xenleta tablets 600 mg every 12 hours to complete the treatment course.
• 600 mg orally every 12 hours for 5 days.

If you take too much Xenleta call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Keep this and all medications out of the reach of children.

Store at room temperature between 68°F to 77°F (20°C to 25°C).