Is Pretomanid approved by the FDA?

Yes, Pretomanid, marketed under the brand name Pretomanid, is FDA approved. The U.S. Food and Drug Administration (FDA) granted approval for Pretomanid on August 14, 2019.

What is Pretomanid?

Pretomanid is an antibiotic classified as a miscellaneous antituberculosis agent. It is specifically used in combination with bedaquiline and linezolid to treat extensively drug-resistant tuberculosis (XDR-TB) in adults. It is not effective for treating latent tuberculosis or tuberculosis affecting parts of the body other than the lungs.

Approved Use

Pretomanid is part of a combination therapy aimed at treating pulmonary extensively drug-resistant tuberculosis or multidrug-resistant tuberculosis (MDR-TB) that is either treatment-intolerant or nonresponsive. This regimen is crucial for managing cases of TB that are resistant to multiple drugs.

Dosage and Administration

Pretomanid is administered in oral tablet form at a dosage of 200 mg. Here is the typical dosing regimen when used in combination with bedaquiline and linezolid:

Pretomanid: 200 mg orally once daily for 26 weeks.
Bedaquiline: 400 mg orally once daily for the first 2 weeks, followed by 200 mg orally three times a week for 24 weeks.
Linezolid: Starting at 1200 mg/day orally for 26 weeks, with potential dose adjustments to 600 mg/day and further reductions to 300 mg/day based on side effects like myelosuppression, peripheral neuropathy, and optic neuropathy.

During the first two weeks, all three medications are taken daily. From week three to week 26, Pretomanid and Linezolid are taken daily, while Bedaquiline is administered three times a week.

Side Effects

Common Side Effects

Nerve problems (numbness, tingling, burning, or prickly sensations)
Heartburn, stomach pain, loss of appetite, nausea, vomiting, diarrhea
Cough, chest pain
Headache, muscle and bone pain
Acne, rash, itching
Abnormal liver or pancreas function tests
Unusual weight loss
Low blood sugar (headache, hunger, sweating, dizziness, fast heart rate, and anxiety)

Serious Side Effects

Allergic reactions (hives, difficulty breathing, swelling of the face, lips, tongue, or throat)
Heart issues (fast/pounding heartbeats, fluttering in the chest, shortness of breath, sudden dizziness)
Vision changes, tremors, weakness, problems with balance
Severe nausea, vomiting, cough with mucus or blood
Liver problems (nausea, loss of appetite, upper right stomach pain, tiredness, itching, dark urine, jaundice)
Low blood cell counts (fever, easy bruising, unusual bleeding, pale skin, feeling light-headed)

Warnings and Precautions

Combination Therapy: Pretomanid must be used in combination with bedaquiline and linezolid and should not be used alone.
Liver and Kidney Disease: Inform your doctor if you have a history of liver disease, kidney disease, heart problems, thyroid issues, seizures, long QT syndrome, HIV, or electrolyte imbalances.
Pregnancy and Breastfeeding: It is not known whether pretomanid is safe for use during pregnancy or breastfeeding. The risks and benefits should be discussed with your healthcare provider. Use effective birth control to prevent pregnancy during treatment and for at least one month after the last dose.
Age Restriction: Pretomanid is not approved for use in individuals younger than 18 years.

How to Take Pretomanid

Take Pretomanid with food and a glass of water. Swallow the tablet whole without crushing, chewing, or breaking it.
The complete regimen typically lasts for 26 weeks, though your doctor may adjust the duration based on your response to treatment.
Store the medication at room temperature, away from moisture and heat.

Missed Dose and Overdose

Missed Dose: If you miss a dose, call your doctor for instructions. Do not take two doses at once.
Overdose: Seek emergency medical attention or contact the Poison Help line at 1-800-222-1222 if you suspect an overdose.

Drug Interactions

Pretomanid can interact with various medications, potentially altering its effectiveness or increasing side effects. Avoid consuming alcohol and be cautious with medications for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV. Many drugs, including prescription, over-the-counter medications, vitamins, and herbal products, can interact with Pretomanid.

Conclusion

Pretomanid, approved by the FDA on August 14, 2019, is a vital medication in the treatment of extensively drug-resistant tuberculosis. It must be used in combination with bedaquiline and linezolid to be effective. Always follow your healthcare provider’s instructions and complete the full course of treatment to avoid developing drug-resistant TB. Consult your doctor with any questions or concerns about your treatment plan.

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