Sotagliflozin

Elpida is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥27 kg/m 2 , who have failed to achieve adequate glycaemic control despite optimal insulin therapy.

Sotagliflozin is an orally delivered dual inhibitor of SGLT1 and SGLT2. Sotagliflozin improves glycaemic and metabolic control through dual inhibition - local inhibition of SGLT1 in the gut and systemic SGLT2 inhibition in the proximal renal tubule. Inhibition of SGLT1 delays and reduces glucose absorption in the proximal intestine, resulting in a blunting and delay of postprandial hyperglycaemia. Inhibition of SGLT2 reduces renal glucose reabsorption and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Sotagliflozin is administered by the oral route. The recommended dose is 200 mg sotagliflozin once daily before the first meal of the day. After at least three months, if additional glycaemic control is needed, in patients tolerating sotagliflozin 200 mg, the dose may be increased to 400 mg once daily.

Interaction studies conducted in healthy volunteers show that Elpida had no clinically relevant effect on the pharmacokinetics of metformin, metoprolol, midazolam and oral contraceptives. Insulin: Insulin may increase the risk of hypoglycaemia. A lower dose of insulin may be required to minimize the risk of hypoglycaemia when used in combination with Elpida

Hypersensitivity to the active substance or to any of the excipients.

Hypotension, renal impairment, hepatic impairment, genital mycotic infections, urinary tract infections, nausea, vomiting, or abdominal pain, excessive thirst, constantly feeling tired, high levels of ketones in urine tests or beta-hydroxybutyrate (BHB) in blood tests, difficulty breathing/rapid, deep breathing, difficulty paying attention, or confusion, rapid weight loss.

There are no data from the use of Sotagliflozin in pregnant women. No data in humans are available on excretion of Sotagliflozin into milk.

Hypotension : Before initiating Elpida, volume status should be assessed and correction on hypovolemia should be made in the elderly, in patients with renal impairment, in patients with low systolic blood pressure and in patients on diuretics since Elpida causes intravascular volume contraction. Impairment in Renal Function : Renal function should be evaluated prior to initiating Elpida and periodically. Initiation of Elpida is not recommended when eGFR is less than 60 ml/min/1.73 m 2 and should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m 2 Hepatic impairment : Elpida is not recommended in patients with moderate and severe hepatic impairment, as Elpida exposure is increased in these patients. Genital mycotic infections : Monitoring and treatment should be done as appropriate. Urinary tract infections : Temporary interruption of Elpida should be considered when treating pyelonephritis and urosepsis.

Multiple doses of 800 mg once daily were administrated in healthy volunteers and these doses were well tolerated. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status.The removal of Elpida by haemodialysis has not been studied.

Do not store above 30°C. Keep away from light and out of the reach of children.