Description
Pretomanid is used as a part of combination dosing regimen with bedaquiline and linezolid to treat tuberculosis (TB) of the lungs that is extensively drug resistant (XDR) or who cannot tolerate or do not respond to treatment for multidrug-resistant (MDR)-TB. Pretomanid prevents the growth of tuberculosis in the body.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of pretomanid in the pediatric population. Safety and efficacy have not been established.
Geriatric
Although appropriate studies on the relationship of age to the effects of pretomanid have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Apalutamide
- Bosentan
- Carbamazepine
- Efavirenz
- Enzalutamide
- Etravirine
- Fosphenytoin
- Lorlatinib
- Lumacaftor
- Mitotane
- Modafinil
- Nafcillin
- Phenobarbital
- Phenytoin
- Primidone
- Rifabutin
- Rifampin
- St John's Wort
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Anemia or
- Leukopenia (low white blood cells) or
- Liver disease or
- Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.
- Heart failure, history of or
- Heart rhythm problems (eg, slow heart rate, long QT syndrome), history of or
- Hypocalcemia (low calcium in the blood) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Hypothyroidism (underactive thyroid), history of or
- Seizures, or history of or—Use with caution. May cause side effects to become worse.
- Tuberculosis, latent or inactive or
- Tuberculosis, multidrug resistant (who can tolerate or respond to medicines used for MDR-TB) or
- Tuberculosis, drug-sensitive or
- Tuberculosis, other types—Should not be used in patients with these conditions.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
Pretomanid must always be taken with bedaquiline and linezolid. Carefully follow your doctor's instructions.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Swallow the tablet whole with water. Do not crush, break, or chew it. Take this medicine with food.
Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For treatment of extensively drug resistant or multi-drug resistant tuberculosis of the lungs:
- Adults—
- Week 1 and 2: 200 milligrams (mg) of pretomanid (1 tablet), 400 mg of bedaquiline, and 1,200 mg of linezolid 1 time each day.
- Week 3 to 26: Take 200 mg of pretomanid (1 tablet) and 1,200 mg of linezolid 1 time each day. Take 200 mg of bedaquiline 3 times a week (at least 48 hours apart).
- Children—Use and dose must be determined by your doctor.
- Adults—
- For treatment of extensively drug resistant or multi-drug resistant tuberculosis of the lungs:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store the medicine in its original container.
Precautions
If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood tests may be needed to check for unwanted effects.
If your symptoms do not improve or if they get worse, call your doctor.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.
Check with your doctor right away if you have any changes to your eyes, such as redness, itching, swelling, or vision changes while you are using this medicine. Your doctor may want you to have your eyes checked by an eye doctor.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.
Lactic acidosis may occur in some patients. Check with your doctor right away if you have fast breathing, trouble breathing, nausea and vomiting, lightheadedness, severe weakness, tiredness, or confusion while using this medicine.
Avoid drinking alcohol while you are using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Abdominal or stomach pain or tenderness
- black, tarry, stools
- bleeding gums
- blindness
- blood in the urine or stools
- blurred vision
- burning, numbness, tingling, or painful sensations
- chills
- clay colored stools
- cough
- dark urine
- decreased appetite
- decreased vision
- eye pain
- fever
- headache
- itching or skin rash
- loss of appetite
- lower back or side pain
- nausea and vomiting
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- sore throat
- swelling of the feet or lower legs
- troubled breathing with exertion
- ulcers, sores, or white spots in the mouth
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- weakness in the arms, hands, legs, or feet
- yellow eyes or skin
Less common
- Chest pain
- coma
- decreased urine output
- dizziness
- drowsiness
- dry mouth
- fast or irregular heartbeat
- increased thirst
- irregular heartbeat
- mood or mental changes
- muscle pain or cramps
- muscle spasms (tetany) or twitching
- numbness or tingling in the hands, feet, or lips
- seizures
- swelling of the face, ankles, or hands
- swollen glands
- trembling
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acid or sour stomach
- belching
- blemishes on the skin
- heartburn
- indigestion
- pimples
- stomach discomfort, upset, or pain
Less common
- Bloating
- change in taste
- constipation
- diarrhea
- dry skin
- loss of taste
- pains in the stomach, side, or abdomen, possibly radiating to the back
- trouble sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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