Usual Adult Dose for Diabetes Type 2

For patients not already taking dapagliflozin:
Initial dose: dapagliflozin 5 mg/saxagliptin 5 mg orally once a day in the morning

For patients tolerating dapagliflozin 5 mg and saxagliptin 5 mg once a day who require additional glycemic control: dapagliflozin 10 mg/saxagliptin 5 mg orally once a day in the morning

Comments:

• Volume depletion should be corrected prior to initiation.
• This combination drug is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

Renal Dose Adjustments

eGFR: 45 mL/min/1.73 m2 or greater: No adjustment recommended
eGFR less than 45 mL/min/1.73 m2: Contraindicated

Liver Dose Adjustments

Use with caution, especially in patients with severe hepatic impairment.

Benefit-risk for use in severe hepatic impairment should be individually assessed since safety and efficacy in this population has not been studied.

Dose Adjustments

Elderly: Dose adjustment may be required due to renal function

Combination use with insulin or an insulin secretagogue: A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia

Concomitant Use with Strong CYP450 3A4/5 Inhibitors: Not Recommended

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active drugs or any of the excipients including anaphylaxis, angioedema, or exfoliative skin conditions
• Moderate to severe renal impairment (eGFR less than 45 mL/min/1.73 m2), ESRD, or dialysis

Dialysis

Contraindicated

Other Comments

Administration advice:

• Take orally once a day in the morning with or without food
• Swallow tablets whole; do not crush, cut, or chew

• Missed dose: If a dose is missed, take as soon as remembered unless it is almost time for next dose, then skip the missed dose; do not take 2 doses at the same time unless instructed by healthcare provider

• Correct volume depletion prior to initiating treatment.
• Consider the risk and benefits of therapy in patients who have known risk factors for heart failure.

• Assess fluid status prior to initiation and monitor for signs and symptoms of volume depletion during therapy
• Verify renal function at baseline, and monitor periodically during therapy
• Monitor for signs and symptoms of acute kidney injury
• Evaluate for the presence of acidosis, including ketoacidosis in symptomatic patients, even if blood sugar is below 250 mg/dL
• Monitor blood glucose and HbA1c
• Monitor for signs and symptoms of heart failure
• Monitor for signs and symptoms of pancreatitis

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Patients should be instructed to maintain adequate fluid intake to avoid adverse reactions related to volume depletion.
• Patients should understand the importance of adhering to dietary instructions and regular physical activity; they should be able to recognize the signs and symptoms of high and low blood sugar and know how to treat.
• During periods of stress such as fever, trauma, infection, or surgery, management of diabetes may change and patients should be advised to seek medical advice.
• Patients should understand that this drug will cause their urine to test positive for glucose.
• Patients experiencing symptoms of ketoacidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue, or sleepiness should be instructed to stop taking this drug and seek immediate medical attention.
• 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 informed that acute pancreatitis, heart failure, allergic reactions, bladder cancer, bullous pemphigoid, genital mycotic infections, serious urinary tract infections, severe and persistent joint pain have occurred; they should be instructed to report these to their healthcare provider or seek medical attention promptly as appropriate.
• 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 who become pregnant, are planning to become pregnant, or are breastfeeding should speak with their healthcare provider.

Frequently asked questions

• What are the ingredient drugs contained in Qternmet XR?