HumuLIN R KwikPen (Concentrated) U-500 and Pretomanid

• Generic Name: insulin regular
• Dosage Forms: n.a.
• Other Brand Names: Humulin R, HumuLIN R KwikPen, Myxredlin, Novolin R

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Concentrated (U-500) insulin is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours. U-500 insulin is five times more concentrated than regular U-100 insulin.

U-500 insulin is used to improve blood sugar control in adults and children with diabetes mellitus who have significant daily insulin needs (more than 200 units per day).

U-500 insulin 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.