SOTAGLIFLOZIN

SGLT-2 Inhibitor

Brand names: INPEFA

Oral

Mechanism of Action

12.1 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.

Indications

1 INDICATIONS AND USAGE INPEFA is indicated to reduce the risk of cardiovascular death

hospitalization for heart failure

and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus

chronic kidney disease

and other cardiovascular risk factors INPEFA is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to reduce the risk of cardiovascular death

hospitalization for heart failure

Contraindications

• 4 CONTRAINDICATIONS INPEFA is contraindicated in patients with a history of serious hypersensitivity reaction to INPEFA. History of serious hypersensitivity reaction to INPEFA. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients with type 1 diabetes mellitus and consider ketone monitoring in others at risk for ketoacidosis, as indicated
1 Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis In patients with type 1 diabetes mellitus, INPEFA significantly increases the risk of diabetic ketoacidosis, a life-threatening event, beyond the background rate
In placebo-controlled trials of patients with type 1 diabetes mellitus, the risk of ketoacidosis was markedly increased in patients who received sodium glucose cotransporter 2 (SGLT2) inhibitors compared to patients who received placebo; this risk may be greater with higher doses of INPEFA
, history of pancreatitis or pancreatic surgery) are also risk factors for ketoacidosis

Known Side Effects

10 documented side effects by frequency

Dizziness

>10%

Diarrhea

>10%

Shortness of Breath

1-10%

Headache

1-10%

UTI

1-10%

Nausea

1-10%

Fatigue

0.1-1%

Vomiting

0.1-1%

Drug Not Working

0.1-1%

General Unwellness

0.1-1%

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Compare With

3 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral