Ertu 15

Type 2 Diabetes Mellitus

Take in the morning qDay, with or without food

Type 2 Diabetes Mellitus Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Recommended starting dose is 5 mg PO qDay in the morning If starting dose tolerated and additional glycemic control is needed, increase dose to maximum of 15 mg qDay Hepatic impairment Mild-to-moderate: No dosage adjustment necessary Severe: Not recommended

<18 years: Safety and efficacy not established

Renal impairment eGFR ?60 mL/min/1.73 m²: No dosage adjustment necessary eGFR <30 mL/min/1.73 m²: Contraindicated End-stage renal disease or dialysis: Contraindicated eGFR 30-60 mL/min/1.73 m² Initiation of ertugliflozin not recommended Continued use not recommended with persistent eGFR 30-60 mL/min/1.73 m²

Hypersensitivity Severe renal impairment, end-stage renal disease, or dialysis

Selective sodium-glucose transporter-2 (SGLT2) inhibitor SGLT-2 inhibition lowers the renal glucose threshold (ie, the plasma glucose concentration, which exceeds the maximum glucose reabsorption capacity of the kidney); lowering the renal glucose threshold results in increased urinary glucose excretion

Causes intravascular volume contraction; symptomatic hypotension may occur after initiating, particularly in patients with renal impairment, with low systolic blood pressure, on diuretics, or who are elderly Ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, has been reported; before initiating, consider factors that may predispose patient to ketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse; monitor for ketoacidosis and temporarily discontinue in clinical situations known to predispose to ketoacidosis (eg, prolonged fasting owing to acute illness or surgery) Renal impairment may occur owing to intravascular volume contraction; before initiating, consider factors that may predispose patients to acute kidney injury, including hypovolemia, chronic renal insufficiency, CHF, and concomitant medications (eg, diuretics, ACE inhibitors, ARBs, NSAIDs); consider temporarily discontinuing ertugliflozin in any setting of reduced oral intake or fluid loss; monitor for signs and symptoms of acute kidney injury, and, if evident, discontinue drug promptly and institute treatment Genital mycotic infections may occur; patients with history of genital mycotic infections and uncircumcised males are more susceptible Serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization reported in patients receiving SGLT2 inhibitors Increases risk of urinary tract infections (UTIs), including life-threatening urospesis and pyelonephritis that started as UTIs

>10% Female genital mycotic infections (9.1-12.2%) 1-10% Volume depletion adverse effects (1.9-4.4%) Male genital mycotic infections (3.7-4.2%) Urinary tract infections (4-4.1%) Headache (2.9-3.5%) Vaginal pruritus (2.4-2.8%) Increased urination (2.4-2.7%) Nasopharyngitis (2-2.5%) Back pain (1.7-2.5%) Renal adverse effects (1.3-2.5%) Weight decreased (1.2-2.4%) Thirst (1.4-2.7%)

Pregnancy Based on animal data showing adverse renal effects, not recommended during the second and third trimesters of pregnancy Data are limited in pregnant women and are not sufficient to determine a drug-associated risk of adverse developmental outcomes; there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy Animal data In animal studies, adverse renal changes were observed in rats when ertugliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy; doses ~13 times the maximum clinical dose caused renal pelvic and tubule dilatations and renal mineralization that were not fully reversible There was no evidence of fetal harm in rats or rabbits at exposures of ertugliflozin ~300 times higher than the maximal clinical dose of 15 mg/day when administered during organogenesis Lactation Not recommended while breastfeeding Unknown if distributed in human breast milk 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 ertugliflozin is not recommended while breastfeeding

Hypoglycemia risk increased with insulin and insulin secretagogues (eg, sulfonylureas); a lower dose of insulin or insulin secretagogue may be required Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors, as SGLT2 inhibitors, increase urinary glucose excretion and lead to positive urine glucose tests; use alternative methods to monitor glycemic control