Ertugliflozin
STEGLATRO
Pronunciation: er-too-gli-FLOE-zin (ste-GLA-troe)
“Ertuğrul, Stegosaurus gladiator”
SGLT2 inhibitor theme
What it isSGLT2 inhibitor; type 2 diabetes.
Why this oneUnlike empagliflozin or dapagliflozin, it has no dedicated heart-failure or chronic-kidney-disease indication.
What limits itGenital fungal infection, volume depletion and euglycemic ketoacidosis occur; hold during acute illness or surgery.
FDA-approved for
- type 2 diabetes (2017)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Type 2 diabetes mellitus — adjunct to diet and exercise for glycemic control | adult | 5 mg QD in the morning | 5–15 mg QD (increase to 15 mg if tolerated and more glycemic control needed) | 15 mg QD |
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
Available strengths
- tab 5, 15 mg
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).
Cost
| Strength | #/mo | generic $/mo | brand $/mo | CostPlus | |
|---|---|---|---|---|---|
| 5 mg | tab | 30 qd | — | $343.09 | not offered |
| 15 mg | tab | 30 qd | — | $343.28 | not offered |
Generic entry2023
NO BOXED WARNINGS
Principal riskIt lacks the outcome data the other gliflozins carry
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityAgent-specific hypoglycemia, ketoacidosis, volume, renal or gastrointestinal toxicity.
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