Qternmet XR Dosage

Prior to Initiation of QTERNMET XR

Assess renal function before initiating QTERNMET XR therapy and periodically thereafter [see WARNINGS AND PRECAUTIONS (5.1, 5.6) and USE IN SPECIFIC POPULATIONS (8.5, 8.6)].

In patients with volume depletion, correct this condition prior to initiation of QTERNMET XR [see WARNINGS AND PRECAUTIONS (5.4, 5.6) and USE IN SPECIFIC POPULATIONS (8.5, 8.6)].

Dosage

Individualize the starting total daily dose of QTERNMET XR based on the patient’s current regimen, effectiveness, and tolerability [see DOSAGE FORMS AND STRENGTHS (3)].

Take QTERNMET XR orally, once daily in the morning with food.

For patients not currently taking dapagliflozin, the recommended starting total daily dose of QTERNMET XR is a 5 mg dapagliflozin/5 mg saxagliptin/1000 mg or 2000 mg metformin hydrochloride (HCl) extended-release once daily.

The maximum recommended daily dose is10 mg dapagliflozin, 5 mg saxagliptin, and 2000 mg metformin HCl extended-release.

Swallow whole. Do not crush, cut or chew the QTERNMET XR tablet. Occasionally, the inactive ingredients of QTERNMET XR will be eliminated in the feces as a soft, hydrated mass that may resemble the original tablet.

If a daily dose is missed and it is greater than or equal to 12 hours until the next dose, the dose should be taken. If a daily dose is missed and it is less than 12 hours until the next dose, the missed dose should be skipped and the next dose taken at the usual time.

Patients with Renal Impairment

No dose adjustment is needed in patients with an estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m2.

QTERNMET XR is contraindicated in patients with an eGFR less than 45 mL/min/1.73 m2 [see CONTRAINDICATIONS (4) and USE IN SPECIFIC POPULATIONS (8.6)].

Use with Strong CYP3A4/5 Inhibitors

Do not coadminister QTERNMET XR with strong cytochrome P450 3A4/5 inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin) [see DRUG INTERACTIONS (7)].

Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue QTERNMET XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with a history of liver disease, alcoholism or heart failure, or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart QTERNMET XR if renal function is stable [see WARNINGS AND PRECAUTIONS (5.1)].