Hypersensitivity to ertugliflozin or any excipient in Ertugliflozin, reactions such as angioedema have occurred.
Patients on dialysis.
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.
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.
Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
