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.
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.
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 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.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking pretomanid?
Do not drink alcohol while taking this antibiotic combination.
What are the possible side effects of pretomanid?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
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 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.
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.
Where can I get more information?
Your doctor or pharmacist can provide more information about pretomanid.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2020 Cerner Multum, Inc. Version: 1.01. Revision date: 12/4/2019.
