Iron sucrose injection and Pretomanid Tablets

• Generic Name: iron sucrose
• Dosage Forms: n.a.
• Other Brand Names: Venofer

Iron sucrose is used to treat iron deficiency anemia in people with kidney disease.

Iron sucrose is for use in adults and children at least 2 years old.

Iron sucrose is not for treating other forms of anemia not caused by iron deficiency.

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

• 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.