Active Ingredient: Pretomanid
Pretomanid is indicated in combination with bedaquiline and linezolid for the treatment of
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 200 milligrams pretomanid, once daily, over the duration of 26 weeks.
Treatment with pretomanid should be initiated and monitored by a physician experienced in the management of TB due to drug-resistant M. tuberculosis.
Pretomanid should be administered by directly observed therapy (DOT) or in accordance with local practice.
The recommended dosage is 200 mg pretomanid once daily, for 26 weeks.
A longer duration of therapy may be considered in patients who have not responded adequately to treatment at 26 weeks on a case by case basis.
Pretomanid should be administered only in combination with bedaquiline (400 mg once daily for 2 weeks followed by 200 mg 3 times per week [with at least 48 hours between doses] orally for a total of 26 weeks) and linezolid (600 mg daily orally for up to 26 weeks).
The product information for bedaquiline and linezolid should be consulted for additional information on the use of these medicinal products.
Any missed doses of pretomanid and bedaquiline should be made up at the end of treatment. Doses of linezolid that are missed due to linezolid adverse reactions should not be made up at the end of treatment.
Refer to the product information of bedaquiline and linezolid for additional information on these medicinal products.
The total duration of treatment with pretomanid in combination with bedaquiline and linezolid is 26 weeks. Data on longer treatment duration is limited. A longer duration of therapy may be considered in patients who have not responded adequately to treatment at 26 weeks on a case by case basis.
There is limited clinical data on the use of pretomanid in elderly patients. Hence, the safety and efficacy of pretomanid in elderly patients have not been established.
Pretomanid should be taken with food.
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