亡。 它是一种可通过咳嗽或打喷嚏传播的空气传播疾病。 每年有超过50万例耐多药结核病例，其中约6％是广泛耐药结核病。 世卫组织目前的数据报告称，有127个国家报告了广泛耐药结核病病例。 由于每年抗菌素耐药性，耐药形式的结核病目前占死亡人数的近三分之一。
Generic name: pretomanid
Dosage form: Tablets
Company: TB Alliance
Treatment for: Tuberculosis, Resistant
Pretomanid is a nitroimidazooxazine antimycobacterial indicated for use in combination with bedaquiline and linezolid (the BPaL regimen) for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).
Limitations of Use:
Pretomanid Tablets are not indicated for patients with:
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 non-responsive 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.
DOSAGE AND ADMINISTRATION
Pretomanid Tablets must be administered only as part of a regimen in combination with bedaquiline and linezolid.
Pretomanid 200 mg orally 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 1,200 mg daily orally for up to 26 weeks, with dose adjustments for known linezolid toxicities.
IMPORTANT SAFETY INFORMATION
Contraindications
Pretomanid Tablets used in combination with bedaquiline and linezolid are contraindicated in patients for whom bedaquiline and/or linezolid is contraindicated.
Warnings and Precautions
Hepatic adverse reactions were reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid. Monitor symptoms and signs and liver‑related laboratory tests. Interrupt treatment with the entire regimen if evidence of liver injury occurs.
Myelosuppression was reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid. Monitor complete blood counts. Decrease or interrupt linezolid dosing if significant myelosuppression develops or worsens.
Peripheral and optic neuropathy were reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid. Monitor visual function. Obtain an ophthalmologic eva luation if there are symptoms of visual impairment. Decrease or interrupt linezolid dosing if neuropathy develops or worsens.
QT prolongation was reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid. Use with drugs that prolong the QT interval may cause additive QT prolongation. Monitor ECGs. Discontinue the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid if significant ventricular arrhythmia or if QTcF interval prolongation of greater than 500 ms develops.
Reproductive effects: Pretomanid caused testicular atrophy and impaired fertility in male rats. Advise patients of reproductive toxicities in animal studies and that the potential effects on human male fertility have not been adequately eva luated.
Lactic acidosis was reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid. Consider interrupting linezolid or the entire combination regimen of Pretomanid |
