Usual Adult Dose for Diabetes Type 2

To improve glycemic control:
Initial dose: 5 mg orally once a day

• May increase to 10 mg orally once a day for additional glycemic control if lower dose has been tolerated

Maximum dose: 10 mg/day

To reduce the risk of hospitalization for heart failure: 10 mg orally once a day

Comments:

• Correct volume depletion prior to initiating therapy.
• Ensure adequate renal function (eGFR greater than 45 mL/min/1.73 m2) as glycemic efficacy is dependent on adequate renal function.
• If used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue should be considered to reduce the risk of hypoglycemia.

Uses:

• As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
• To reduce the risk of hospitalization for heart failure in patients with type 2 diabetes mellitus and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors.

Usual Adult Dose for Heart Failure with Reduced Ejection Fraction

10 mg orally once a day

Comments:

• Correct volume depletion prior to initiating therapy.
• This drug is not recommended for patients with type 1 diabetes mellitus.

Use: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction.

Usual Adult Dose for Chronic Kidney Disease

10 mg orally once a day

Comments:

• Correct volume depletion prior to initiating therapy.
• This drug is not recommended in patients with polycystic kidney disease or patients requiring, or with a recent history of immunosuppressive therapy for kidney disease, as it is not expected to be effective.
• This drug is not recommended for patients with type 1 diabetes mellitus.

Use: To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and
hospitalization for heart failure in adults with chronic kidney disease at risk of progression.

Renal Dose Adjustments

For Glycemic Control in Patients with Type 2 Diabetes Mellitus:

• eGFR 45 mL/min/1.73 m2 or greater: No adjustment recommended
• eGFR less than 45 mL/min/1.73 m2: Use is not recommended

For all other indications:

• eGFR greater than 25 mL/min/1.73 m2: No adjustment recommended
• eGFR less than 25 mL/min/1.73 m2: Initiation is not recommended, however patients may continue 10 mg/day

Liver Dose Adjustments

Mild to moderate hepatic impairment; No adjustment recommended
Severe hepatic impairment: Use caution as the safety and efficacy has not been specifically studied

Precautions

CONTRAINDICATIONS:

• Serious hypersensitivity reaction to this drug (e.g., anaphylactic reactions or angioedema)
• 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 in the morning, with or without food

Missed Dose: If a dose is missed, take it as soon as it is remembered, if it is almost time for the next dose, the missed dose should be skipped; do not take 2 doses at the same time.

General:

• Correct volume depletion prior to initiating treatment; dehydration may increase the risk for hypotension.
• Not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis

Monitoring:

• Assess fluid status prior to initiation and monitor for signs and symptoms of volume depletion during therapy
• Obtain baseline renal function and monitor periodically during therapy
• Monitor for signs and symptoms of acute kidney injury
• Evaluate for ketoacidosis in symptomatic patients, even if blood sugar is below 250 mg/dL

Patient advice:

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Patients should understand that this drug will cause the urine to test positive for glucose.
• Patients should be instructed to maintain adequate fluid intake.
• Patients should be instructed to seek medical advice during periods of stress or illness as medical management of diabetes may change.
• Patients should understand 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 experiencing symptoms of ketoacidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue, or sleepiness should be instructed to stop this drug and seek immediate medical attention.
• Patients should be instructed to seek prompt medical attention for signs and symptoms of acute kidney injury such as decreased urine, swelling in the legs or feet.
• Women who are pregnant or considering becoming pregnant should speak with their healthcare provider; women should not breastfeed while taking this drug.

Frequently asked questions

• What are the ingredient drugs contained in Qternmet XR?