Pretomanid is an antibiotic used in combination with bedaquiline and linezolid to treat extensively drug-resistant tuberculosis in adults.

pretomanid will not treat tuberculosis that is not active (latent), or tuberculosis that affects parts of the body other than the lungs.

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

Pretomanid must be given in combination with other antibiotic medications and should not be used alone. Follow your doctor's instructions very carefully.

Pretomanid must be given in combination with bedaquiline and linezolid and should not be used alone. Use all 3 medicines as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor's advice.

Pretomanid is taken with food and a glass of water. Swallow the tablet whole and do not crush, chew, or break it.

Pretomanid, bedaquiline, and linezolid are usually given for a total of 26 weeks. Your doctor will tell you if you need to use the medicines for longer than 26 weeks.

During the first 2 weeks, all 3 medications are taken daily. During week 3 through week 26, only pretomanid and linezolid are taken daily and bedaquiline is taken 3 times per week, at least 48 hours apart.

You may need to take this drug combination while being observed by a healthcare professional. Your doctor may occasionally change your dose, or tell you to stop using the medicines. Follow all instructions very carefully.

You will need frequent blood tests to check your blood cells and liver function before and during treatment with this medicine.

Use your medications 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. Pretomanid will not treat a viral infection such as the flu or a common cold.

If you keep this medicine at home, store it in the original container at room temperature, away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Tuberculosis -- Resistant:

Pretomanid: 200 mg orally once a day for 26 weeks
Bedaquiline: 400 mg orally once a day for 2 weeks followed by 200 mg orally 3 times a week (at least 48 hours between doses) for 24 weeks (for a total of 26 weeks)
Linezolid: Starting at 1200 mg/day orally for 26 weeks (with dose adjustment to 600 mg/day and further reduction to 300 mg/day or dose interruption as needed for known linezolid side effects of myelosuppression, peripheral neuropathy, and optic neuropathy)

Discontinuation of Dosing:
-If this drug or bedaquiline are discontinued, the entire combination regimen should also be discontinued.
-If linezolid is permanently discontinued during the initial 4 consecutive weeks of therapy, bedaquiline and this drug should also be discontinued; if linezolid is discontinued after the initial 4 weeks of consecutive therapy, administration of bedaquiline and this drug should continue.

Comments:
-If the combination regimen is interrupted by a healthcare provider for safety reasons, missed doses can be made up at the end of therapy; doses of linezolid alone (missed due to linezolid side effects) should not be made up.
-Dosing of the combination regimen can be extended beyond 26 weeks, if needed.

Use: As part of a combination regimen with bedaquiline and linezolid, for the treatment of patients with pulmonary extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB)

Tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• heart problems;

• a underactive thyroid;

• a seizure;

• long QT syndrome (in you or a family member);

• HIV; or

• low levels of calcium, potassium, or magnesium in your blood.

pretomanid may affect fertility (ability to have children) in men.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether pretomanid will harm an unborn baby. However, having tuberculosis during pregnancy may cause serious complications in both the mother and the baby. The benefit of treating tuberculosis may outweigh any risks to the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Pretomanid is not approved for use by anyone younger than 18 years old.

Call your doctor for instructions if you miss a dose of pretomanid, bedaquiline, or linezolid.

If your doctor tells you to stop taking the antibiotic combination, follow all instructions for taking the missed doses at the end of your treatment.

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

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.

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

Do not drink alcohol while taking this antibiotic combination.

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

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

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• tremors, weakness, problems with balance;

• vision changes;

• severe ongoing nausea and vomiting;

• cough with mucus or blood;

• shortness of breath, chest pain that gets worse when you breathe or cough;

• nerve problems--numbness, tingling, burning, or prickly feeling in your arms, hands, legs, or feet;

• liver problems--nausea, loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, jaundice (yellowing of the skin or eyes); or

• low blood cell counts--fever, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed.

Common side effects of pretomanid may include:

• nerve problems;

• heartburn, stomach pain, loss of appetite, nausea, vomiting, diarrhea;

• cough, chest pain;

• headache, muscle and bone pain;

• acne, rash, itching;

• abnormal blood tests that check the function of your liver or pancreas;

• unusual weight loss; or

• low blood sugar--headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky.

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.

Pretomanid 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 pretomanid. 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.

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.