Pretomanid

Pretomanid

SELF ADMINISTRATION - ORAL 

Indications for Prior Authorization:

• Pretomanid is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). 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 the following conditions:
    • Drug-sensitive (DS) tuberculosis
    • Latent infection due to Mycobacterium tuberculosis.
    • Extra-pulmonary infection due to Mycobacterium tuberculosis.
    • MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy. 
    • 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.

Patients must meet the following criteria for the indication(s) above:

• Patient is 18 years of age or older, AND
• Chart note documentation is provided and confirms the tuberculosis is either:
  • pulmonary XDR (resistance to isoniazide and rifampin, plus any fluoroquinolone, AND at least 1 injectable (eg, capreomycin, kanamycin, or amikacin)) OR
  • treatment-intolerant OR nonresponsive MDR (resistance to at least 2 first-line drugs including at least isoniazid and rifampin), AND
• Prescribed by infectious disease, pulmonology or tuberculosis expert, AND
• Patient meets the limitations of use, AND
• Will be taken in combination with both bedaquiline and linezolid

Dosing:

• Must be administered in combo with bedaquiline and linezolid:

  • Pretomanid Tablet 200 mg orally (1 tablet of 200 mg), once daily, for 26 weeks
  • Bedaquiline 400 mg orally once daily for 2 weeks followed by 200 mg 3 times per week, with at least 48 hours between doses, for 24 weeks for a total of 26 weeks
  • Linezolid starting at 1,200 mg orally per day for 26 weeks, with dose adjustments to 600 mg daily and further reduction to 300 mg daily or interruption of dosing as necessary for known linezolid adverse reactions of myelosuppression, peripheral neuropathy, and optic neuropathy
  • If the combination regimen of Pretomanid, bedaquiline, and linezolid is interrupted by a healthcare provider for safety reasons, missed doses can be made up at the end of the treatment; doses of linezolid alone missed due to linezolid adverse reactions should not be made up.
  • Dosing of the combination regimen of Pretomanid, bedaquiline, and linezolid can be extended beyond 26 weeks, if necessary

Approval:

• 1 treatment (26 weeks)