SOTAGLIFLOZIN TAB,ORAL
Clinical Criteria Summary
Indications
- Reduce the risk of cardiovascular death, hospitalization for heart failure (HF), and urgent HF visit in adults with:
- HF or
- Type 2 diabetes mellitus (T2DM), chronic kidney disease (CKD), and other CV risk factors
Dosing & Administration Criteria
- Recommended starting dose is 200 mg once daily, administered not more than one hour before the first meal of the day
- After 2 weeks, the dose may be titrated to 400 mg once daily, as tolerated
- Withhold for at least three days prior to major surgery or procedures associated with prolonged fasting (if possible)
Pre-Initiation Assessment & Monitoring Requirements
- Assess volume status and correct volume depletion if indicated before starting
- Assess renal function prior to initiation and as clinically indicated
- In patients with decompensated HF, dosing may begin only when the patient is hemodynamically stable
- Monitor for signs and symptoms of hypotension and renal function after starting therapy
- Evaluate patients for signs and symptoms of urinary tract infections during therapy and treat promptly if indicated
- Monitor and treat genital mycotic infections as appropriate
Contraindications
- History of serious hypersensitivity reaction to sotagliflozin
Warnings & Precautions (Clinical Use Criteria)
- Not indicated for glycemic control; not approved for T1DM due to significantly increased risk of diabetic ketoacidosis (DKA)
- Assess for ketoacidosis regardless of presenting blood glucose and discontinue if suspected; monitor patients for resolution before restarting
- Increased risk for volume depletion in patients with impaired renal function (eGFR < 60 ml/min/1.73 m2), elderly patients, or patients on loop diuretics
- May increase risk of hypoglycemia when combined with insulin or an insulin secretagogue; a lower dose of these agents may be required to minimize risk
- Assess for necrotizing fasciitis of the perineum (Fournier’s gangrene) if patients present with pain, tenderness, erythema, or swelling in the genital or perineal area along with fever or malaise; discontinue sotagliflozin and provide alternative HF therapy if suspected
Clinical Practice Guideline Recommendations
- ACC/AHA/HFSA (2022): Recommended to reduce hospitalization for HF and CV mortality in symptomatic chronic HFrEF irrespective of T2DM; can be beneficial in HFmrEF and HFpEF; recommended for management of hyperglycemia and to reduce HF morbidity/mortality in patients with HF and T2DM
- ESC (2021): Recommended in patients with diabetes at high risk of CV disease or with CV disease to prevent HF hospitalizations; recommended in patients with T2DM at risk of CV events to reduce HF hospitalizations, major CV events, end-stage renal dysfunction, and CV death; recommended in patients with T2DM and HFrEF to reduce HF hospitalizations and CV death
- ADA (2023/2022): Recommended for adults with T2DM and established/high risk of atherosclerotic CV disease, HF, and/or CKD to reduce cardiorenal risk; recommended as part of glucose-lowering regimen independent of A1C; recommended for T2DM and diabetic kidney disease with eGFR ≥ 25 ml/min/1.73 m2 and urinary albumin ≥ 300 mg/g creatinine to reduce CKD progression and CV events