Pretomanid is an antibiotic indicated as part of a combination regimen with bedaquiline and linezolid for treatment of adults with pulmonary extensively drug-resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).

Pretomanid will not treat tuberculosis that is not active (latent) or tuberculosis that affects parts of the body other than the lungs.

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

Nitroimidazooxazine antimycobacterial drug; kills actively replicating M. tuberculosis by inhibiting mycolic acid biosynthesis, thereby blocking cell wall production.

Under anaerobic conditions, against nonreplicating bacteria, pretomanid acts as a respiratory poison following nitric oxide release.

All of these activities require nitro-reduction of pretomanid within the mycobacterial cell by deazaflavin-dependent nitroreductase (Ddn), which is dependent on the reduced form of cofactor F420.

Take with food.

Swallow the tablet whole with water.

Must be used only in combination with bedaquiline and linezolid as part of the recommended dosing regimen.

Emphasize the need for compliance with the full course of therapy to patients.

Administer a combination regimen of pretomanid, bedaquiline, and linezolid by directly observed therapy.

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

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.

Store at room temperature <86ºF (30ºC).

Missed doses for safety reasons: Can be made up at the end of treatment.

Doses of linezolid alone missed owing to linezolid adverse reactions should not be made up.

Dosing of the combination regimen can be extended beyond 26 weeks, if necessary.

If either bedaquiline or pretomanid is discontinued, the entire combination regimen should also be discontinued.

Linezolid is permanently discontinued during the initial 4 consecutive weeks; bedaquiline and pretomanid should also be discontinued.

Linezolid was discontinued after the initial 4 consecutive weeks: Continue administering bedaquiline and pretomanid.

Pretomanid side effects can vary depending on the individual. Always consult your healthcare provider.