Indications of Pretomanid

Indicated Population:

Pretomanid tablets are indicated, as part of a combination regimen with bedaquiline and linezolid, for the treatment of adults with pulmonary tuberculosis resistant to isoniazid, rifamycins, a fluoroquinolone, and a second-line injectable antibacterial agent, or for the treatment of adults with pulmonary tuberculosis resistant to isoniazid and rifampin who are intolerant of or have not responded to standard therapy. This indication is approved based on limited clinical safety and efficacy data. This product is intended for a limited and specific patient population.

Limitations of Use:

Pretomanid tablets are not indicated for patients with:

Drug-susceptible tuberculosis.

Latent infection due to Mycobacterium tuberculosis.

Extrapulmonary infection due to Mycobacterium tuberculosis.

Tuberculosis resistant to isoniazid and rifampin but responding to standard therapy and not intolerant to it.

Tuberculosis with known resistance to any component of the combination regimen.

The safety and efficacy of pretomanid tablets in combination with drugs other than bedaquiline and linezolid in the recommended dosing regimen have not been established.