Fingolimod and Pretomanid

• Generic Name: fingolimod
• Dosage Forms: n.a.
• Other Brand Names: Gilenya

Fingolimod is used to treat relapsing multiple sclerosis (MS) in adults and children who are at least 10 years old. This medication will not cure MS, it will only decrease the frequency of relapse symptoms.

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

• Generic Name: pretomanid
• Dosage Forms: n.a.
• 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.