Pretomanid (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- PRETOMANID
Indications and Usage
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)].
Contraindications
Pretomanid Tablets used in the combination regimen with bedaquiline and linezolid are contraindicated in patients for whom bedaquiline and/or linezolid are contraindicated. Refer to the bedaquiline and linezolid prescribing information.
Adverse Reactions
The following serious adverse reactions are discussed here and elsewhere in the labeling: •Hepatotoxicity [see Warnings and Precautions (5.2)] •Myelosuppression [see Warnings and Precautions (5.3)] •Peripheral and Optic Neuropathy [see Warnings and Precautions (5.4)] •QT Prolongation [see Warnings and Precautions (5.5)] •Reproductive Effects [see Warnings and Precautions (5.7)] •Lactic Acidosis [see Warnings and Precautions (5.8)]
Mechanism of Action
Pretomanid is a nitroimidazooxazine antimycobacterial drug [see Microbiology (12.4) ].
Overdosage
There is no experience with the treatment of acute overdose with pretomanid. Take general measures to support basic vital functions including monitoring of vital signs and ECG (QT interval) in case of deliberate or accidental overdose.