Pretomanid

Pretomanid is an antibiotic used along 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 taken together with bedaquiline and linezolid and should not be used by itself. 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 taken for a total of 26 weeks. Your doctor will inform you if you need to use the medicines for longer than 26 weeks.

During the first 2 weeks, all 3 medications are taken daily. From 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.

Pretomanid must be given along with other antibiotic medications and should never be used on its own. Follow your doctor's instructions very closely.

Tell your doctor if you have ever had:

• liver disease;
• kidney disease;
• heart problems;
• an 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 for 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.

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

Pretomanid may cause serious side effects. Call your doctor immediately if you experience:

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (as if you might pass out);
• tremors, weakness, difficulty with balance;
• changes in vision;
• severe ongoing nausea and vomiting;
• cough with mucus or blood;
• shortness of breath, chest pain that worsens when you breathe or cough;
• nerve issues—numbness, tingling, burning, or prickly sensations in your arms, hands, legs, or feet;
• liver issues—nausea, loss of appetite, upper right stomach pain, 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 issues;
• 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 the FDA at 1-800-FDA-1088.

Usual Adult Dose for Tuberculosis -- Resistant:

Pretomanid: 200 mg orally once a day for 26 weeksBedaquiline: 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 OR 200 mg orally once a day for 8 weeks followed by 100 mg orally once a day for 18 weeks-Total duration: 26 weeksLinezolid:-Preferred regimen: 600 mg orally once a day for 26 weeks---If myelosuppression, peripheral neuropathy, or optic neuropathy occurs: Reduce dosage to 300 mg orally once a day or interrupt linezolid dosing.-Alternative regimen: 1200 mg orally once a day 26 weeks---If myelosuppression, peripheral neuropathy, and optic neuropathy occurs: Reduce dosage to 600 mg orally once a day, further reduce dosage to 300 mg orally once a day, or interrupt linezolid.Discontinuation of Dosing:-If this drug or bedaquiline are discontinued: Discontinue the entire combination regimen.-If linezolid is permanently discontinued during the initial 4 consecutive weeks of therapy: Discontinue bedaquiline and this drug.-If linezolid is discontinued after the initial 4 weeks of consecutive therapy: Continue administration of bedaquiline and this drug.Comments:-This drug must be administered in combination with bedaquiline and linezolid.-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 tuberculosis (TB) resistant to isoniazid, rifamycins, a fluoroquinolone, and a second line injectable antibacterial agent OR patients with pulmonary TB resistant to isoniazid and rifampin, who are treatment-intolerant or nonresponsive to standard therapy

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

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

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

Do not drink alcohol while taking this antibiotic combination.

Sometimes it is not safe to use certain medications together. Some drugs can change the levels of other drugs in your blood, 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 take 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 the medicines you are currently taking and any medicine you start or stop using.