Ertuglif 15

• Type 2 Diabetes Mellitus: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use: Not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Ertugliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, ertugliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Adult Dose:

• Type 2 Diabetes Mellitus: Recommended starting dose: 5 mg PO qDay in the morning; may increase to maximum of 15 mg qDay if needed.
• Mild-to-moderate hepatic impairment: No dosage adjustment necessary.
• Severe hepatic impairment: Not recommended.

Renal Dose:

• eGFR ≥60 mL/min/1.73 m²: No dosage adjustment necessary
• eGFR 30-60 mL/min/1.73 m²: Initiation not recommended; continued use not recommended
• eGFR <30 mL/min/1.73 m², ESRD, or dialysis: Contraindicated

Child Dose (<18 years): Safety and efficacy not established.

Common Side Effects:

• Female genital mycotic infections (9.1-12.2%)
• Volume depletion adverse effects (1.9-4.4%)
• Male genital mycotic infections (3.7-4.2%)
• Urinary tract infections (4-4.1%)
• Headache (2.9-3.5%)
• Vaginal pruritus (2.4-2.8%)
• Increased urination (2.4-2.7%)
• Nasopharyngitis (2-2.5%)
• Back pain (1.7-2.5%)
• Renal adverse effects (1.3-2.5%)
• Weight decreased (1.2-2.4%)
• Thirst (1.4-2.7%)

Use in Pregnancy: Based on animal data, not recommended during the second and third trimesters. Limited data in pregnant women.

Precautions:

• Hypotension: Causes intravascular volume contraction; caution in patients with renal impairment, low systolic BP, on diuretics, or elderly.
• Ketoacidosis: Serious life-threatening condition; risk factors include insulin deficiency, caloric restriction, alcohol abuse; temporarily discontinue in acute illness or surgery.
• Acute Kidney Injury: Risk factors include hypovolemia, chronic renal insufficiency, CHF, concomitant medications; temporarily discontinue if reduced oral intake or fluid loss.
• Genital Mycotic Infections: History or uncircumcised males are more susceptible.
• Serious UTIs: Urosepsis and pyelonephritis requiring hospitalization reported.
• LDL-C Increases: Monitor and treat as appropriate.

Overdose: In the event of overdose, contact the Poison Control Center. Employ usual supportive measures as dictated by the patient's clinical status. Removal by hemodialysis has not been studied.

Storage: Store at 30°C or below in a dry place.