H.P. Acthar Gel and Pretomanid

• Generic Name: corticotropin
• Dosage Forms: injection
• Other Brand Names:

  Acthar Gel, HP, Acthar, ACTH Gel, ACTH-80, ACTH-40 HP

Acthar Gel, H.P. is a hormone that is used to treat many different conditions such as multiple sclerosis, psoriatic or rheumatoid arthritis, ankylosing spondylitis, lupus, severe allergic reactions, breathing disorders, and inflammatory conditions of the eyes.

Acthar Gel, H.P. is also used to treat infantile spasms in children younger than 2 years old.

Acthar Gel, H.P. can reduce the symptoms of many disorders, but it is not a cure for these conditions. This medicine is also not expected to slow the progress of any disease.

Acthar Gel, H.P. 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.