Ertugliflozin pidolate

STEGLATRO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 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. Limitations of Use: Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus.

SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Ertugliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, ertugliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Assess renal function before initiating and as clinically indicated. Correct volume depletion before initiating STEGLATRO. Recommended starting dosage is 5 mg orally once daily, taken in the morning, with or without food. Increase dosage to 15 mg orally once daily in those tolerating STEGLATRO and needing additional glycemic control. Use is not recommended in patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m 2. Withhold STEGLATRO for at least 4 days, if possible, prior to surgery or procedures associated with prolonged fasting.

STEGLATRO is contraindicated in patients with hypersensitivity to ertugliflozin or any excipient in STEGLATRO. Reactions such as angioedema have occurred. Hypersensitivity to ertugliflozin or any of the excipients in STEGLATRO.

Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients at risk for ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue STEGLATRO if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. Lower Limb Amputation: Monitor patients for infections or ulcers of lower limbs, and institute appropriate treatment. Volume Depletion: May result in acute kidney injury. Before initiating, assess and correct volume status in patients with renal impairment or low systolic blood pressure, elderly patients, or patients on diuretics. Monitor for signs and symptoms during therapy.

The following important adverse reactions are described elsewhere in the labeling: Diabetic Ketoacidosis in Patients with Type 1 Diabetes and Other Ketoacidosis Lower Limb Amputation Volume Depletion Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), and Genital Mycotic Infections Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues Most common adverse reactions (incidence ≥ 5%) were female genital mycotic infections.

Table 3: Clinically Significant Drug Interactions with STEGLATRO Insulin or Insulin Secretagogues Clinical Impact: The risk of hypoglycemia is increased when STEGLATRO is used in combination with insulin or an insulin secretagogue. Intervention: A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with STEGLATRO. Lithium Clinical Impact: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Intervention: Monitor serum lithium concentration more frequently during STEGLATRO initiation and dosage changes. Positive Urine Glucose Test Clinical Impact: SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Intervention: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors.

Store at 20°C -25°C (68°F -77°F), excursions permitted between 15°C -30°C (between 59°F -86°F). Protect from moisture. Store in a dry place.