Inpefa

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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Inpefa Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Sotagliflozin 200mg, 400mg; tabs.

    Pharmacological Class

    Sodium-glucose co-transporter 2 (SGLT2) inhibitor.

    How Supplied

    Tabs—30, 90

    Storage

    Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. 

    Manufacturer

    Lexicon Pharmaceuticals

    Generic Availability

    NO

    Mechanism of Action

    Sotagliflozin is an inhibitor of SGLT2 and SGLT1. Inhibiting SGLT2 reduces renal reabsorption of glucose and sodium which may influence several physiological functions such as lowering both pre-and afterload of the heart and downregulating sympathetic activity. Inhibiting SGLT1 reduces intestinal absorption of glucose and sodium which likely contributes to diarrhea. The mechanism for sotagliflozin’s cardiovascular benefits has not been established.

    Inpefa Indications

    Indications

    To reduce risk of cardiovascular death, hospitalization for heart failure (HF), and urgent HF visits in adults with HF or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors. 

    Inpefa Dosage and Administration

    Adult

    Swallow whole. Initially 200mg once daily (at ≤1hr before the first meal of the day). After ≥2 weeks, titrate up to 400mg once daily as tolerated; may down-titrate to 200mg as needed.

    Children

    <18yrs: not established.

    Inpefa Contraindications

    Not Applicable

    Inpefa Boxed Warnings

    Not Applicable

    Inpefa Warnings/Precautions

    Warnings/Precautions

    Not for glycemic control. Correct volume depletion prior to initiation. Increased risk for volume depletion or hypotension in those with renal impairment (eGFR <60mL/min/1.73m2), elderly, or on loop diuretics. Assess volume status and renal function prior to initiation; monitor during therapy. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected; evaluate and treat if confirmed. Monitor for resolution of ketoacidosis before restarting. Withhold prior to major surgery (for ≥3 days) or procedures associated with prolonged fasting; resume when clinically stable. Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative therapy for HF. Increased risk of genital mycotic infections or UTIs; monitor and treat appropriately. Moderate or severe hepatic impairment: not recommended. Elderly. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.

    Inpefa Pharmacokinetics

    Absorption

    Median time to maximum plasma concentration (Tmax): range 1.25–3 hours.

    Distribution

    Plasma protein bound: >93%. 

    Mean apparent volume of distribution: 9000 L (after a single 400mg dose).

    Metabolism

    Hepatic (primarily UGT1A9).

    Elimination

    Renal (57%), fecal (37%); after a single 400mg dose.

    Inpefa Interactions

    Interactions

    Consider a lower dose of concomitant insulin or insulin secretagogue to reduce risk of hypoglycemia. May potentiate concomitant digoxin; monitor. May be antagonized by UGT inducers (eg, rifampicin). Monitor lithium levels. May result in false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glucose levels.

    Inpefa Adverse Reactions

    Adverse Reactions

    Urinary tract infection, volume depletion, diarrhea, hypoglycemia; ketoacidosis, urosepsis, pyelonephritis, genital mycotic infections; rare: Fournier's gangrene.

    Inpefa Clinical Trials

    Clinical Trials

    The approval was based on data from the multicenter, randomized, double-blind, placebo-controlled phase 3 SOLOIST-WHF (ClinicalTrials.gov Identifier: NCT03521934) and SCORED (ClinicalTrials.gov Identifier: NCT03315143) studies.

    SOLOIST-WHF evaluated the CV efficacy of sotagliflozin in 1222 hemodynamically stable adults with type 2 diabetes who had recently been hospitalized for worsening HF (median left ventricular ejection fraction was 35%). SCORED evaluated the CV efficacy of sotagliflozin in 10,584 adults with type 2 diabetes, CKD (estimated glomerular filtration rate of 25-60mL/min/1.73m2), and additional CV risk factors (eg, history of HF, obesity, dyslipidemia, hypertension, or elevated cardiac and inflammatory biomarkers).

    Patients were randomly assigned to receive sotagliflozin or placebo orally once daily, in addition to standard of care. The primary endpoint for both studies was the total occurrence (first and potentially subsequent) of CV death, hospitalization for HF, and urgent HF visits after randomization.

    In both trials, sotagliflozin was superior to placebo in reducing the primary composite endpoint. In SOLOIST-WHF, the number of primary endpoint events per 100 patient-years was 51.3 in the sotagliflozin arm and 76.4 in the placebo arm (hazard ratio [HR], 0.67; 95% CI, 0.53-0.85; P =.001). In SCORED, the number of primary endpoint events per 100 patient-years was 5.6 in the sotagliflozin arm and 7.5 in the placebo arm (HR, 0.75; 95% CI, 0.63-0.88; P <.001).

    Inpefa Note

    Not Applicable

    Inpefa Patient Counseling

    Cost Savings Program

    Inpefa Together: Savings and Resources

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