Xenleta is used to treat certain types of pneumonia in adults.

Xenleta may also be used for purposes not listed in this medication guide.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Xenleta oral is taken by mouth.

Take Xenleta oral on an empty stomach, at least 1 hour before or 2 hours after a meal.

Take Xenleta oral with a full glass (6 to 8 ounces) of water. Swallow the tablet whole and do not crush, chew, or break it.

Xenleta injection is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Xenleta injection must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Xenleta injection must be given slowly, and the infusion can take about 60 minutes to complete.

You will need frequent blood tests to check your liver function.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Xenleta will not treat a viral infection such as the flu or a common cold.

Store the tablets at room temperature away from moisture and heat.

Store Xenleta injection in the refrigerator, do not freeze. Store the diluent bags at room temperature.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

After mixing Xenleta injection with the diluent, you may store the mixture for up to 24 hours at room temperature, or up to 48 hours in a refrigerator.

You should not use Xenleta if you are allergic to it.

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with Xenleta. Your doctor may change your treatment plan if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor if you have ever had:

• a heart rhythm disorder (especially if you take medication to treat it);

• long QT syndrome;

• liver disease; or

• kidney disease (or if you are on dialysis).

You may need to have a negative pregnancy test before starting this treatment.

Xenleta may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using Xenleta and for at least 2 days after your last dose. Tell your doctor if you become pregnant.

You should not breastfeed within 2 days after using Xenleta. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 8 hours. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Do not share Xenleta with another person, even if they have the same symptoms you have.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Xenleta may cause serious side effects. Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose); or

• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects of Xenleta may include:

• nausea, vomiting, diarrhea;

• sleep problems (insomnia);

• low potassium;

• headache;

• abnormal liver function tests; or

• pain, bruising, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Xenleta can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect Xenleta. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.