Usual Adult Dose for Diabetes Type 2

Initial dose: 1 tablet (ertugliflozin 5 mg/sitagliptin 100 mg) orally once a day

• For patients tolerating therapy and requiring additional glycemic control, may increase to 1 tablet (ertugliflozin 15 mg/sitagliptin 100 mg) orally once a day

Maximum dose: ertugliflozin 15 mg/sitagliptin 100 mg per day

For patients already receiving ertugliflozin: Switch to combination product with same ertugliflozin dose

Comments:

• Volume depletion should be corrected prior to initiating therapy.
• This drug is not recommended for patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis in these patients.
• This drug has not been studied in patients with a history of pancreatitis; it is not known whether this may increase the risk of developing pancreatitis during therapy.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Renal Dose Adjustments

eGFR 45 mL/min/1.73 m2 or greater: No dose adjustment recommended
eGFR less than 45 mL/min/1.73 m2): Not recommended
Severe renal impairment (eGFR 30 mL/min/1.73m2), ESRD, or dialysis: Contraindicated

Liver Dose Adjustments

Mild to moderate hepatic impairment: No dose adjustment recommended
Severe hepatic impairment: Not recommended

Dose Adjustments

Elderly: No dosage adjustment recommended based on age: elderly patients are more likely to have renal impairment; assess renal function more frequently

Concomitant Use of Insulin and Insulin Secretagogues:

• A lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycemia.

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to active substances or product excipients; reactions such as anaphylaxis or angioedema have occurred
• Severe renal impairment (eGFR less than 30 mL/min/1.73 m2), ESRD, or dialysis

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Contraindicated

Other Comments

Administration advice:

• Take orally once a day in the morning, with or without food

Missed dose: If a dose is missed, take as soon as remembered; do not double next dose.

General:

• Correct volume depletion prior to initiating treatment.
• Not recommended for patients with type 1 diabetes mellitus.
• Has not been studied in patients with a history of pancreatitis; it is unknown whether these patients may be at an increased risk for the development of pancreatitis.

Monitoring:

• Assess fluid status prior to initiation and monitor for signs and symptoms of volume depletion during therapy
• Obtain renal function prior to initiating therapy and as clinically indicated
• Evaluate for the presence of ketoacidosis in symptomatic patients, regardless of blood sugar reading
• Monitor for new pain or tenderness, sores or ulcers, or infections involving the leg or foot
• Monitor for pancreatitis
• Monitor for signs and symptoms of heart failure
• Monitor for genital mycotic infections and urinary tract infections
• Monitor glycemic control

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Instruct patients experiencing symptoms of ketoacidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue, or sleepiness to stop taking this drug and seek immediate medical attention.
• Patients should be instructed to maintain adequate fluid intake to avoid adverse reactions related to volume depletion such as orthostatic hypotension.
• Patients should understand the importance of adhering to dietary instructions, regular physical exercise, and routine lab monitoring; they should understand how to treat low and high blood sugars and when to seek medical advice (for example, during periods of stress as medical management of glycemic control may change).
• Inform patients that genital mycotic infections, urinary tract infections, and hypersensitivity reactions may occur; patients should be instructed to contact their health care professional.
• Patients should be instructed to seek immediate medical attention for symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, especially if they have a fever and are feeling unwell.
• Patients should be instructed to seek medical attention promptly for signs and symptoms of acute kidney injury such as decreased urine, swelling in the legs or feet.
• Patients should be instructed to promptly report new pain or tenderness, sores or ulcers, or infections involving the leg or foot.
• Instruct patient to report signs and symptoms of pancreatitis; if persistent, severe abdominal pain occurs, seek medical advice promptly.
• Women of childbearing potential should be advised to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
• Instruct patients to contact their health care provider if they develop severe and persistent joint pain.