INPEFA Tablet Ref.[107315] Active ingredients: Sotagliflozin

2.1 Prior to Initiation of INPEFA

Assess volume status and, if necessary, correct volume depletion prior to initiation of INPEFA [see Warnings and Precautions (5.2) and Use in Specific Populations (8.5, 8.6)].

Assess renal function prior to initiation of INPEFA and then as clinically indicated [see Warnings and Precautions (5.2)].

For patients with decompensated heart failure, dosing may begin as soon as the patient is hemodynamically stable, including during hospitalization or urgent outpatient treatment or immediately upon discharge.

2.2 Recommended Dosage

The recommended starting dose of INPEFA is 200 mg orally once daily not more than one hour before the first meal of the day.

Up-titrate after at least 2 weeks to 400 mg orally once daily as tolerated [see Clinical Studies (14)]. Down-titrate to 200 mg as necessary [see Adverse Reactions (6.1), Warnings and Precautions (5) and Use in Specific Populations (8.6)].

Swallow tablets whole. Do not cut, crush, or chew tablets.

If a dose of INPEFA is missed by more than 6 hours, take the next dose as prescribed the next day.

2.3 Temporary Interruption for Surgery

Withhold INPEFA at least 3 days, if possible, prior to major surgery or procedures associated with prolonged fasting. Resume INPEFA when the patient is clinically stable and has resumed oral intake [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3)].

There were no confirmed reports of symptomatic overdose with sotagliflozin during the clinical development program of INPEFA.

In the event of an overdose with INPEFA, contact the Poison Control Center. Employ the usual supportive measures as dictated by the patient’s clinical status.

The removal of sotagliflozin by hemodialysis has not been studied.

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].