Ertugliflozin/Metformin

DEA Class; Rx

Common Brand Names; Segluromet

Indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin

Hypersensitivity to drug or excipients; reactions such as angioedema or anaphylaxis have occurred

Severe renal impairment (eGFR <30 mL/min/1.73 m²), end-stage renal disease, or dialysis

Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma

Female genital mycotic infections (9.1-12.2%)

(Ertugliflozin)

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%)

(Metformin)

Initiating drug

• Diarrhea
• Nausea
• Vomiting
• Flatulence
• Abdominal discomfort
• Indigestion
• Asthenia
• Headache

Long-term use

• Decreased vitamin B-12 absorption, which may very rarely result in significant deficiency (eg, megaloblastic anemia)

Cases of metformin-associated lactic acidosis reported, including fatalities (see Black Box Warnings and Contraindications)

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

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

Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated; serious urinary tract infections, including urosepsis and pyelonephritis, requiring hospitalization reported in patients receiving SGLT2 inhibitors

Genital mycotic infections may occur; patients with history of genital mycotic infections and uncircumcised males are more susceptible

Dose-related increases in LDL-C reported

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

Ertugliflozin

• Based on animal data showing adverse renal effects, not recommended during the second and third trimesters of pregnancy

Metformin

• Published data from postmarketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy

Lactation

Not recommended while breastfeeding

Ertugliflozin/Metformin

tablet

• 2.5mg/500mg
• 2.5mg/1000mg
• 7.5mg/500mg
• 7.5mg/1000mg