2. INDICATIONS AND USAGE 

QTERN (dapagliflozin and saxagliptin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) who have inadequate control with dapagliflozin or who are already treated with dapagliflozin and saxagliptin [see Clinical Studies].

Limitations of Use

QTERN is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.

QTERN should only be used in patients who tolerate 10 mg dapagliflozin.

3. DOSAGE AND ADMINISTRATION 

3.1 Dosage

In patients with volume depletion, correct this condition prior to initiation of QTERN [see Warnings and Precautions (5.3), and Use in Specific Populations (8.5, 8.6)].

The recommended dose of QTERN is a 10 mg dapagliflozin/5 mg saxagliptin tablet taken orally once daily in the morning with or without food.

Do not split or cut QTERN tablets.

3.2 Patients with Renal Impairment

Assessment of renal function is recommended prior to initiation of QTERN therapy and periodically thereafter.

Do not initiate QTERN in patients with an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2.

Discontinue QTERN if eGFR falls persistently below 60 mL/min/1.73 m2 [see Warnings and Precautions (5.5) and Use in Specific Populations (8.6)].

QTERN is contraindicated in patients with an eGFR less than 45 mL/min/1.73 m2 [see Contraindications (4)].

3.3 Use with Strong CYP3A4/5 Inhibitors

Do not coadminister QTERN with strong cytochrome P450 3A4/5 inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin) [see Drug Interactions (7.1)].

4. CONTRAINDICATIONS 

QTERN is contraindicated in patients with:

• History of a serious hypersensitivity reaction to dapagliflozin or to saxagliptin, including anaphylaxis, angioedema or exfoliative skin conditions [see Warnings and Precautions (5.8) and Adverse Reactions (6.1)].

• Moderate to severe renal impairment (eGFR less than 45 mL/min/1.73 m2), end-stage renal disease (ESRD), or patients on dialysis [see Use in Specific Populations (8.6)].

5. WARNINGS AND PRECAUTIONS 

5.1 Pancreatitis

There have been postmarketing reports of acute pancreatitis in patients taking saxagliptin. In a cardiovascular outcomes trial enrolling participants with established atherosclerotic cardiovascular disease (ASCVD) or multiple risk factors for ASCVD (SAVOR trial), cases of definite acute pancreatitis were confirmed in 17 of 8240 (0.2%) patients receiving saxagliptin compared to 9 of 8173 (0.1%) receiving placebo. Pre-existing risk factors for pancreatitis were identified in 88% (15/17) of those patients receiving saxagliptin and in 100% (9/9) of those patients receiving placebo.

After initiation of QTERN, observe patients for signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue QTERN and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using QTERN.

5.2 Heart Failure

In a cardiovascular outcomes trial enrolling participants with established ASCVD or multiple risk