Home Drug Guide Sotagliflozin

Drug Guide

Generic Name

Sotagliflozin

Brand Names Inpefa

Classification

Therapeutic: Antidiabetic agent

Pharmacological: SGLT2 and SGLT1 inhibitor

FDA Approved Indications

Type 1 diabetes mellitus as adjunct to insulin in adults

Mechanism of Action

Sotagliflozin inhibits sodium-glucose cotransporters 1 and 2 (SGLT1 and SGLT2), reducing glucose reabsorption in the kidneys and glucose absorption in the intestines, leading to decreased blood glucose levels.

Dosage and Administration

Adult: Start with 200 mg once daily; can increase to 400 mg based on response and tolerability.

Pediatric: Not approved for pediatric use.

Geriatric: No specific initial dose adjustment; monitor renal function closely.

Renal Impairment: Use caution; renal function should be assessed prior to initiation and periodically during treatment.

Hepatic Impairment: Data limited; use with caution and monitor patients closely.

Pharmacokinetics

Absorption: Orally absorbed; peak plasma concentrations in approximately 1.5 hours.

Distribution: Wide distribution; volume of distribution approximately 104 L.

Metabolism: Primarily metabolized by glucuronidation (UGT1A9 and UGT2B7 pathways).

Excretion: Excreted via urine and feces; renal excretion approximately 55%.

Half Life: Approximate half-life of 14 hours.

Contraindications

Severe renal impairment (eGFR <30 mL/min/1.73 m²)
End-stage renal disease
Dialysis

Precautions

Risk of diabetic ketoacidosis, especially in T1DM
Monitor for dehydration, hypotension, urinary tract infections, and genital mycotic infections
Assess renal function regularly

Adverse Reactions - Common

Genital mycotic infections (Common)
Urinary tract infections (Common)
Hypovolemia/dehydration (Common)

Adverse Reactions - Serious

Diabetic ketoacidosis (Rare but serious)
Kidney injury (Rare)

Drug-Drug Interactions

Diuretics (risk of volume depletion)
Insulins and other hypoglycemics (risk of hypoglycemia)

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor blood glucose, renal function, and signs of volume depletion.

Diagnoses:

Risk for hypoglycemia
Risk for dehydration
Risk for urinary tract infection

Implementation: Administer with or without food at the same time daily; monitor for adverse effects.

Evaluation: Assess blood glucose control and adverse effects regularly.

Patient/Family Teaching

Take medication exactly as prescribed.
Monitor blood sugar levels regularly.
Report signs of dehydration, genital infections, or symptoms of ketoacidosis.
Maintain good hygiene to prevent infections.

Special Considerations

Black Box Warnings:

Risk of diabetic ketoacidosis (DKA), especially in type 1 diabetes.
Serious urinary tract infections and genital infections.

Genetic Factors: Genetic variations may influence drug metabolism and response.

Lab Test Interference: May affect serum glucose and renal function tests.

Overdose Management

Signs/Symptoms: Hypovolemia, hypotension, hypoglycemia, ketoacidosis.

Treatment: Discontinue medication, provide supportive care including hydration, monitor metabolic parameters, and treat ketoacidosis with insulin and fluids as indicated.

Storage and Handling

Storage: Store at room temperature away from moisture and heat.

Stability: Stable until expiration date on the package.