HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use STEGLUJAN safely and effectively. See full prescribing information for STEGLUJAN. 

STEGLUJAN™ (ertugliflozin and sitagliptin) tablets, for oral use 

Initial U.S. Approval: 2017 

INDICATIONS AND USAGE 

STEGLUJAN is a combination of ertugliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate. (1) 

Limitations of Use: 

Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. (1)

Has not been studied in patients with a history of pancreatitis. (1, 5.1)

DOSAGE AND ADMINISTRATION 

Recommended starting dose is 5 mg ertugliflozin/100 mg sitagliptin once daily, taken in the morning, with or without food. (2.1)

Increase dose to 15 mg ertugliflozin/100 mg sitagliptin once daily in those tolerating STEGLUJAN and needing additional glycemic control. (2.1)

Assess renal function before initiating STEGLUJAN and periodically thereafter (2.2): Do not use in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2.

Initiation is not recommended in patients with an eGFR of 30 to less than 60 mL/min/1.73 m2.

Continued use is not recommended in patients with an eGFR persistently between 30 and less than 60 mL/min/1.73 m2.

DOSAGE FORMS AND STRENGTHS 

Tablets: 

Ertugliflozin 5 mg and sitagliptin 100 mg (3)

Ertugliflozin 15 mg and sitagliptin 100 mg (3)

CONTRAINDICATIONS 

Severe renal impairment, end stage renal disease, or dialysis. (4, 5.4)

History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. (4, 5.10, 6.2)

History of serious hypersensitivity reaction to ertugliflozin. (4)

WARNINGS AND PRECAUTIONS 

Pancreatitis: There have been postmarketing reports of acute pancreatitis in patients taking sitagliptin, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue. (5.1)

Hypotension: May occur particularly in patients with renal impairment, the elderly, or patients on diuretics. Before initiating assess and correct volume status. Monitor for signs and symptoms during therapy. (5.2) 

Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue, eva luate and treat promptly. Before initiating, consider risk factors for ketoacidosis. Patients may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis. (5.3) 

Acute Kidney Injury and Impairment in Renal Function: Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue and promptly treat. There have been postmarketing reports of acute renal failure in patients taking sitagliptin, sometimes requiring dialysis. Monitor renal function. (5.4)