HIGHLIGHTS OF PRESCRIBING INFORMATION 

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

STEGLATRO™ (ertugliflozin) tablets, for oral use 

Initial U.S. Approval: 2017 

INDICATIONS AND USAGE 

STEGLATRO is a sodium glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) 

Limitations of Use: 

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

DOSAGE AND ADMINISTRATION 

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

Increase dose to 15 mg once daily in those tolerating STEGLATRO and needing additional glycemic control. (2.1)

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

Initiation is not recommended in patients with an eGFR of 30 to less than 60 mL/minute/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: 5 mg and 15 mg (3)

CONTRAINDICATIONS 

Severe renal impairment, end-stage renal disease, or dialysis. (4, 5.3)

Histoy of serious hypersensitivity reaction to STEGLATRO. (4)

WARNINGS AND PRECAUTIONS 

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. (5.1)

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. (5.2)

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. Monitor renal function. (5.3)

Urosepsis and Pyelonephritis: eva luate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated. (5.4)

Lower Limb Amputation: Before initiating, consider factors that may increase risk of amputation. Monitor patients for infections or ulcers of lower limbs, and discontinue if these occur. (5.5)

Hypoglycemia: Consider a lower dose of insulin or insulin secretagogue to reduce risk of hypoglycemia when used in combination. (5.6)

Genital Mycotic Infections: Monitor and treat if indicated. (5.7)

Increased LDL-C: Monitor and treat as appropriate. (5.8)

ADVERSE REACTIONS 

The most common adverse reactions associated with STEGLATRO (incidence ≥ 5%) were female genital mycotic infections. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.