Pretomanid

Y. Vivian Tsai, Pharm.D., Edina Avdic, Pharm.D.
Pediatric Dosing Author: Lisa Hutchins, Pharm.D.

INDICATIONS

FDA

  • Pulmonary TB resistant to isoniazid, rifamycins, a fluoroquinolone, and a second-line injectable antibacterial drug, or pulmonary TB resistant to isoniazid and rifampin that is treatment-intolerant or nonresponsive to standard therapy.
    • Note: FDA indication is different from current WHO XDR-TB, which means MDR/RR-TB plus fluoroquinolone resistance and resistance to bedaquiline or linezolid.
    • Limitations of Use: Pretomanid is not indicated for patients with drug-sensitive TB, latent TB, extra-pulmonary infection due to M. tuberculosis, or MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy
    • Safety and effectiveness have not been established in combination with drugs other than bedaquiline and linezolid.

NON-FDA APPROVED USES

  • The 2025 ATS/CDC/ERS/IDSA guideline supports BPaLM for FQ-susceptible RR-TB and BPaL for RR-TB with FQ resistance or intolerance in persons ≥14 years.
  • The 2026 WHO guideline further stratifies pulmonary pre-XDR-TB by disease severity, recommending BPaL for non-severe disease and BPaLC for severe disease in eligible patients.[20]

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