ErtuMet

ErtuMet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.

Individualize the starting dose is based on the patient's current regimen, while not exceeding the maximum recommended daily dose of 15 mg ertugliflozin and 2,000 mg metformin:
In patients on metformin, switch to this tablet containing 2.5 mg ertugliflozin, with a similar total daily dose of metformin.
In patients on ertugliflozin, switch to this tablet containing 500 mg metformin, with a similar total daily dose of ertugliflozin.
In patients already treated with ertugliflozin and metformin, switch to this tablet containing the same total daily dose of ertugliflozin and a similar daily dose of metformin.
Take this tablet twice daily with meals, with gradual dose escalation for those initiating metformin to reduce the gastrointestinal side effects due to metformin.
Dosing may be adjusted based on effectiveness and tolerability.
Use of this tablet is not recommended in patients with an eGFR less than 45 mL/min/1.73 m2.
Use of this tablet is contraindicated in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2), end stage-renal disease (ESRD), or on dialysis.

Most common adverse reactions associated with ertugliflozin (incidence ≥5%) were female genital mycotic infections.
Most common adverse reactions associated with metformin (incidence ≥5%) were diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache.

Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue, evaluate, 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.
Lower Limb Amputation: Consider factors that may increase the risk of amputation before initiating SEGLUROMET. Monitor patients for infections or ulcers of lower limbs, and discontinue if these occur.
Volume Depletion: May result in acute kidney injury. Before initiating, assess and correct volume status in patients with renal impairment, low systolic blood pressure, elderly patients, or patients on diuretics. Monitor for signs and symptoms during therapy.
Urosepsis and Pyelonephritis: Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.
Hypoglycemia: Consider a lower dose of insulin or insulin secretagogue to reduce risk of hypoglycemia when used in combination.
Necrotizing Fasciitis of the Perineum (Fournier's Gangrene): Serious, life-threatening cases have occurred in both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment.
Genital Mycotic Infections: Monitor and treat if indicated.
Vitamin B12 Deficiency: Metformin may lower vitamin B12 levels. Measure hematological parameters annually.
Lactic Acidosis

Ertugliflozin
: 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.
Metformin
: Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Metformin does not produce hypoglycemia in either patients with type 2 diabetes mellitus or normal subjects (except in special circumstances) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.