Ertoxa

Ertugliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

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.

Prior to Initiation of Ertugliflozin: Assess renal function prior to initiation of Ertugliflozin and as clinically indicated. In patients with volume depletion, correct this condition before initiating Ertugliflozin.

Recommended Dosage:

• The recommended starting dose of Ertugliflozin is 5 mg once daily, taken in the morning, with or without food.
• For additional glycemic control, the dose may be increased to 15 mg once daily in patients tolerating Ertugliflozin.
• Use of Ertugliflozin is not recommended in patients with an eGFR less than 45 mL/min/1.73 m².
• Ertugliflozin is contraindicated in patients on dialysis.

Pediatric Use: The safety and effectiveness of Ertugliflozin in pediatric patients under 18 years of age have not been established.

Geriatrics: Higher incidence of adverse reactions related to reduced intravascular volume.

Renal Impairment: Higher incidence of adverse reactions related to reduced intravascular volume and renal function.

The following important adverse reactions are described elsewhere in the labeling:

• Ketoacidosis 
• Lower Limb Amputation 
• Volume Depletion
• Urosepsis and Pyelonephritis
• Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
• Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)
• Genital Mycotic Infections

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 Ertugliflozin. 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 or 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.

Based on animal data showing adverse renal effects, Ertugliflozin is not recommended during the second and third trimesters of pregnancy. There is no information regarding the presence of Ertugliflozin in human milk, the effects on the breastfed infant, or the effects on milk production. Ertugliflozin is present in the milk of lactating rats. Since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. Because of the potential for serious adverse reactions in a breastfed infant, advise women that the use of Ertugliflozin is not recommended while breastfeeding.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.