Health Vidya

Limited Population: Pretomanid Tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary tuberculosis (TB) resistant to isoniazid, rifamycins, a fluoroquinolone and a second line injectable antibacterial drug OR adults with pulmonary TB resistant to isoniazid and rifampin, who are treatment-intolerant or nonresponsive to standard therapy. Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients. Limitations of Use: •Pretomanid Tablets are not indicated in patients with: oDrug-sensitive (DS) TB oLatent infection due to Mycobacterium tuberculosis oExtra-pulmonary infection due to Mycobacterium tuberculosis oTB resistant to isoniazid and rifampin who are responsive to standard therapy and not treatment-intolerant oTB with known resistance to any component of the combination •Safety and effectiveness of Pretomanid Tablets have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen [see Dosage and Administration (2.2)].