Inpefa

— THERAPEUTIC CATEGORIES —
  • CHF and arrhythmias

Inpefa Generic Name & Formulations

General Description

Sotagliflozin 200mg, 400mg; tabs.

Pharmacological Class

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

How Supplied

Tabs—30, 90

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; consider risk factors before initiation (eg, acute febrile illness, insulin deficiency, caloric restriction, alcohol abuse). 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

See Literature

Inpefa Note

Not Applicable

Inpefa Patient Counseling

See Literature

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