SEIZ

Indications

• Type 1 diabetes mellitus
• Glycemic control in conjunction with insulin therapy

Dosage

Children: Refer to BNF for Children for specific dosing recommendations.

Adults: Refer to BNF for specific dosing recommendations.

Mechanism of action

Sotagliflozin inhibits the sodium-glucose co-transporters SGLT1 and SGLT2. SGLT1 is responsible for glucose absorption in the gastrointestinal tract, while SGLT2 is involved in glucose reabsorption in the kidneys. By inhibiting SGLT1, sotagliflozin delays glucose absorption, lowering postprandial blood glucose levels. Inhibition of SGLT2 decreases the reabsorption of glucose in the kidneys, leading to increased urinary glucose excretion.

Pharmacodynamics

The pharmacologic effects of sotagliflozin include slowing glucose absorption in the gastrointestinal tract and promoting glucose excretion in urine. The drug is administered orally once daily before the first meal of the day. Caution is advised as sotagliflozin may increase the risk of diabetic ketoacidosis (DKA), particularly in patients with a higher baseline risk. Furthermore, the increased urinary glucose excretion can raise the likelihood of genital infections.

Pharmacokinetics

Sotagliflozin demonstrates favorable pharmacokinetic properties, allowing for once-daily oral dosing. It is absorbed from the gastrointestinal tract and distributed throughout the body. The drug undergoes hepatic metabolism, and its elimination half-life supports its once-daily dosing schedule. Renal function may influence its pharmacokinetics, and dose adjustments may be necessary in patients with impaired renal function.

Contra-indications

• Hypersensitivity to sotagliflozin or any of its excipients
• Severe renal impairment (eGFR < 30 mL/min/1.73 m²)
• Diabetic ketoacidosis
• Type 1 diabetes mellitus

Adverse effects

• Urinary tract infections
• Genital infections
• Diabetic ketoacidosis
• Hypoglycemia when used with insulin or insulin secretagogues
• Gastrointestinal disturbances such as diarrhea and nausea
• Hypotension
• Increased urination

Interactions

• Potential increased risk of dehydration and hypotension with diuretics
• Increased risk of hypoglycemia when used with insulin or insulin secretagogues
• Caution when used with other antihyperglycemic agents

Precautions

• Monitor renal function prior to and during treatment
• Assess for history of urinary tract infections or genital infections
• Educate patients on the signs and symptoms of diabetic ketoacidosis
• Use with caution in patients with a history of pancreatitis

Pregnancy

The safety of sotagliflozin during pregnancy has not been established. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is unknown whether sotagliflozin is excreted in human milk. Caution should be exercised when administering to breastfeeding women.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

• Tablets: 200 mg, 400 mg

Mechanism of action

Sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2) are integral in the transport of glucose in the body. SGLT1 is the major transporter for glucose absorption in the gastrointestinal tract, while SGLT2 is the predominant transporter responsible for reabsorption of glucose in the glomerulus. Sotagliflozin is a dual inhibitor of both SGLT1 and SGLT2. Inhibition of SGLT1 results in a delay in glucose absorption and a blunting of postprandial hyperglycemia, while inhibition of SGLT2 reduces renal reabsorption of filtered glucose, thereby increasing urinary glucose excretion.

Pharmacodynamics

Sotagliflozin exerts its pharmacologic effects by slowing glucose absorption in the gastrointestinal tract and increasing the excretion of glucose in the urine. It is administered by mouth once daily before the first meal of the day. The use of SGLT2 inhibitors, including sotagliflozin, can cause diabetic ketoacidosis (DKA). Patients, especially those with a higher baseline risk of DKA, should be instructed on how and when to monitor for ketoacidosis and what actions to take when DKA is suspected. SGLT2 inhibitors, including sotagliflozin, also increase the risk of genital infections. This is due to the increase in urinary glucose excretion, which provides a relatively glucose-rich environment in which infectious agents may establish themselves.