Ertugliflozin

FDA label

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Renal Not recommended if eGFR <45 mL/min/1.73 m2; no dosage adjustment if eGFR >=45. Assess renal function before initiating and as clinically indicated.

Hepatic No adjustment in mild-moderate impairment; not studied and not recommended in severe hepatic impairment

Instructions

• Take in the morning, with or without food
• Assess renal function and correct volume depletion before initiating
• Withhold >=4 days (if possible) before surgery or procedures with prolonged fasting; resume when clinically stable and eating
• Missed dose: take as soon as possible; do not double the next dose

Cautions

• Diabetic ketoacidosis (may be euglycemic; fatal cases reported) — not for type 1 diabetes; withhold in predisposing situations; discontinue and evaluate if suspected
• Lower limb amputation — increased event rate in cardiovascular outcomes trial; monitor for foot ulcers/infections
• Volume depletion — may cause acute kidney injury; assess/correct before starting (renal impairment, low SBP, elderly, diuretics)
• Genitourinary infections: urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene), genital mycotic infections
• Hypoglycemia with insulin or insulin secretagogues — consider lowering their dose

Adverse reactions

• Female genital mycotic infections (9.1–12.2%; most common)
• Male genital mycotic infections (3.7–4.2%)
• Urinary tract infections (~4%)
• Headache, vaginal pruritus, increased urination, nasopharyngitis, back pain, weight decrease, thirst (>=2%)

Pregnancy Not recommended in 2nd/3rd trimesters (adverse renal effects during renal development in animal studies).

Lactation Not recommended — present in rat milk; potential risk to developing infant kidney (maturation through ~2 years).