pretomanid

What is the most important information I should know about pretomanid?

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

What is pretomanid?

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

This medicine 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.

What should I discuss with my healthcare provider before taking pretomanid?

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.

This medicine 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.

How should I take pretomanid?

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, 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 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.

What happens if I miss a dose?

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.

What happens if I overdose?

What should I avoid while taking pretomanid?

What are the possible side effects of pretomanid?

• 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 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.

What other drugs will affect pretomanid?

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.

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.

Where can I get more information?

Your doctor or pharmacist can provide more information about pretomanid.