Sotagliflozin
INPEFA
Pronunciation: soe-ta-gli-FLOE-zin (in-PE-fa)
“Soda flows In pee”
SGLT2 inhibitor theme
What it isDual SGLT1/SGLT2 inhibitor; heart-failure and cardiorenal risk reduction.
Why this oneSGLT1 blockade adds an intestinal effect, giving postprandial glucose control that pure SGLT2 inhibitors lack.
What limits itIntestinal blockade causes diarrhea; euglycemic ketoacidosis and genital fungal infection remain major hazards.
FDA-approved for
- heart failure (2023)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Heart failure | Adults | 200 mg QD | 400 mg QD | 400 mg QD |
Titration Up-titrate after at least 2 weeks (from 200 mg to 400 mg QD as tolerated)
Renal No specific dose adjustment; higher incidence of volume-depletion reactions in renal impairment; assess renal function before initiation
Hepatic Undefined
In decompensated heart failure, begin dosing once the patient is hemodynamically stable
Instructions
- Take once daily no more than 1 hour before the first meal of the day
- Swallow tablets whole; do not cut, crush, or chew
- Correct volume status before initiating
- Withhold at least 3 days before major surgery or procedures with prolonged fasting
- If a dose is missed by more than 6 hours, take the next dose the next day
Available strengths
- tab 200, 400 mg
Cautions
- Diabetic ketoacidosis (type 1 diabetes and others at risk)
- Volume depletion / hypotension
- Genitourinary infections incl. urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's gangrene), genital mycotic infections
- Hypoglycemia with concomitant insulin or insulin secretagogues
Adverse reactions
- Urinary tract infection
- Volume depletion
- Diarrhea
- Hypoglycemia
Pregnancy Not recommended during the second and third trimesters (animal renal effects)
Lactation Not recommended while breastfeeding
Cost
| Strength | #/mo | generic $/mo | brand $/mo | CostPlus | |
|---|---|---|---|---|---|
| 200 mg | tab | 30 qd | — | $611.08 | not offered |
| 400 mg | tab | 30 qd | — | not offered |
Generic entry2030 est.
NO BOXED WARNINGS
Principal riskDiarrhea from SGLT1 blockade; ketoacidosis in type 1
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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