Pretomanid

Pretomanid is used along with bedaquiline (Sirturo) and linezolid (Zyvox) to treat multi-drug resistant tuberculosis (MDR-TB; a serious infection that affects the lungs that cannot be treated with other medications) in adults. Pretomanid is in a class of medications called antimycobacterials. It works by killing the bacteria that cause tuberculosis.

Pretomanid comes as a tablet to take by mouth. It is usually taken once daily with food for 26 weeks or longer. Take pretomanid at around the same time 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 pretomanid 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 water.

Continue to take pretomanid until you finish the prescription and do not miss doses, even if you feel better. If you stop taking pretomanid too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics. This will make your infection harder to treat in the future. You will participate in a directly observed therapy program to make sure you to take all of your medication as directed. In this program, a healthcare worker will give you each dose of medication and will watch as you swallow the medication.

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

Before taking pretomanid,

• tell your doctor and pharmacist if you are allergic to pretomanid, bedaquiline, linezolid, any other medications, or any of the ingredients in pretomanid tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking pretomanid. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following herbal product may interact with pretomanid: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking pretomanid. Do not start this medication while taking pretomanid without discussing with your healthcare provider.
• tell your doctor if you or a family member have long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death), or another type of irregular heart beat or heart rhythm problem. Also, tell your doctor if you have or have ever had low blood levels of calcium, magnesium or potassium in your blood, a heart attack, heart failure (HF; condition in which the heart cannot pump enough blood to other parts of the body), seizures, HIV infection, or thyroid, liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pretomanid, call your doctor.
• you should know to avoid drinking alcoholic beverages. Drinking alcohol increases the risk that you will experience serious side effects from pretomanid.

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

Take the missed dose as soon as you remember it. Do not take a double dose to make up for a missed one.

Pretomanid may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• acne
• headache
• heartburn
• loss of appetite
• weight loss
• rash
• itching
• stomach pain
• nausea
• vomiting
• diarrhea
• constipation
• dry skin
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• loss of appetite, nausea, yellow eyes or skin, pain in the upper right area of the stomach, or dark urine
• pain, numbness, or weakness in hands, feet, or other parts of the body; or problems with balance
• vision changes
• fast or irregular heartbeat; feeling dizzy; or fainting
• pale skin or extreme tiredness
• repeated nausea and vomiting; fast breathing; confusion; or feeling tired
• sudden, stabbing pain in the chest, particularly when breathing in and out

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

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. https://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 (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to pretomanid. You will need to have an electrocardiogram (ECG; a test that measures the electrical activity of the heart) before your treatment and several times during your treatment to see how this medication affects your heart rhythm.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.