Drug Interactions between Inpefa and lorcaserin

ADJUST DOSING INTERVAL: Coadministration with a high-caloric meal may increase the bioavailability of sotagliflozin. When coadministered with a high-caloric breakfast, sotagliflozin peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 149% and 50%, respectively, compared to fasting conditions. Multiple sotagliflozin doses (400 mg) administered immediately before breakfast, 30 minutes before breakfast, and 1 hour before breakfast in healthy subjects showed a consistent effect on urine glucose excretion, insulin, and postprandial glucose across all dose schedules.

GENERALLY AVOID: Alcohol may cause hypoglycemia or hyperglycemia in patients with diabetes. Hypoglycemia most frequently occurs during acute consumption of alcohol. Even modest amounts can lower blood sugar significantly, especially when the alcohol is ingested on an empty stomach or following exercise. The mechanism involves inhibition of both gluconeogenesis as well as the counter-regulatory response to hypoglycemia. Episodes of hypoglycemia may last for 8 to 12 hours after ethanol ingestion. By contrast, chronic alcohol abuse can cause impaired glucose tolerance and hyperglycemia. Moderate alcohol consumption generally does not affect blood glucose levels in patients with well controlled diabetes.

MANAGEMENT: Sotagliflozin should be administered no more than 1 hour before the first meal of the day. Patients with diabetes should avoid consuming alcohol if their blood glucose is not well controlled, or if they have hypertriglyceridemia, neuropathy, or pancreatitis. Patients with well controlled diabetes should limit their alcohol intake to one drink daily for women and two drinks daily for men (1 drink = 5 oz wine, 12 oz beer, or 1.5 oz distilled spirits) in conjunction with their normal meal plan. Alcohol should not be consumed on an empty stomach or following exercise.

Food does not appear to significantly affect the absorption and oral bioavailability of lurasidone. In twelve adult volunteers (6 men and 6 women), administration of a single 10 mg oral dose of lorcaserin following a high-fat (approximately 50% of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal resulted in less than 10% increases in lorcaserin peak plasma concentration (Cmax) and systemic exposure (AUC) compared to administration in the fasted state. The time to reach peak concentration (Tmax) was delayed by approximately 1 hour in the fed state. Lorcaserin may be administered with or without food.