Ertugliflozin

DEA Class; Rx

Common Brand Names; Steglatro

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Hypersensitivity to ertugliflozin or any excipient; reactions such as angioedema have occurred

Patients on dialysis

• Female genital mycotic infections (9.1-12.2%)
• 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%)
• Adverse Effects
• Necrotizing fasciitis of the perineum (Fournier’s Gangrene)
• Angioedema

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; before initiating treatment in patients with one or more of risk factors, assess volume status and renal function

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 urosepsis and pyelonephritis that started as UTIs

Necrotizing fasciitis of the perineum (Fournier gangrene) reported with SGLT2 inhibitors; signs and symptoms include tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4°F or a general feeling of being unwell; if suspected, discontinue SGLT2 inhibitor and start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary

Dose-related increases in LDL-C reported

No conclusive evidence of macrovascular risk reduction with empagliflozin or any other antidiabetic agent

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

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

Ertugliflozin

tablet

• 5mg
• 15mg