Pretomanid Tablets and Rapamune

• Generic Name: pretomanid
• Dosage Forms: tablet
• Other Brand Names:

Limited Population: Pretomanid is an antimycobacterial indicated as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), 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.

Pretomanid is not indicated for patients with: drug-sensitive (DS) tuberculosis, latent infection due to Mycobacterium tuberculosis, extrapulmonary infection due to M. tuberculosis, or MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy.

Safety and effectiveness of pretomanid have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen.

• Generic Name: sirolimus
• Dosage Forms: oral solution, tablets
• Other Brand Names: Rapamune

Rapamune weakens your body's immune system, to help keep it from "rejecting" a transplanted organ such as a kidney. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

Rapamune is used with other medicines to prevent organ rejection after a kidney transplant.

Rapamune is also given without other medicines to treat a rare lung disorder called lymphangioleiomyomatosis (lim-FAN-gee-oh-LYE-oh-MYE-oh-ma-TOE-sis). This disorder happens mostly in women and causes lung tumors that are not cancerous but can affect breathing.

Rapamune may also be used for purposes not listed in this medication guide.