Drug Detail:Ertugliflozin (Ertugliflozin [ er-too-gli-floe-zin ])
Drug Class: SGLT-2 inhibitors
Usual Adult Dose for Diabetes Type 2
Initial dose: 5 mg orally once a day in the morning
- May increase to 15 mg orally once a day for patients tolerating therapy and requiring additional glycemic control
Comments:
- Volume depletion should be corrected prior to initiating therapy.
- This drug is not recommended for patients with type 1 diabetes mellitus; it may increase the risk of diabetic ketoacidosis in these patients.
Use: 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
Liver Dose Adjustments
Mild to moderate hepatic impairment: No dose adjustment recommended
Severe hepatic impairment: Not recommended
Dose Adjustments
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:
- Serious hypersensitivity reaction to this drug, or any product excipients; angioedema has occurred
- 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 as it may increased the risk of diabetic ketoacidosis in these patients.
Monitoring:
- Assess fluid status prior to initiation and monitor for signs and symptoms of volume depletion during therapy
- Obtain baseline renal function and repeat 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
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.
- Explain to patients that this drug will cause urine to test positive for glucose.
- 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.
- Women of childbearing potential should be advised to speak to their healthcare provider if they become pregnant or intend to become pregnant; breastfeeding is not recommended while taking this drug.