ertugliflozin and sitagliptin
Drug Details
- Generic Name
- ertugliflozin and sitagliptin
- Brand Names
- STEGLUJAN
- Application Number
- NDA209805
- Sponsor
- Organon Heist
- NDC Codes
- 4
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- ERTUGLIFLOZIN PIDOLATE, SITAGLIPTIN PHOSPHATE
Indications and Usage
1 INDICATIONS AND USAGE STEGLUJAN ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ]. Has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using STEGLUJAN [see Warnings and Precautions (5.2) ] . STEGLUJAN is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. ( 1 ) Has not been studied in patients with a history of pancreatitis. ( 1 , 5.2 )