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QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets(五)
ize 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 QTERNMETXR 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 metforminHCl extended-release.
Swallow whole. Do not crush, cut or chew the QTERNMET XR tablet. Occasionally, the inactiveingredients of QTERNMET XR will be eliminated in the feces as a soft, hydrated mass that may resemblethe 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 betaken. If a daily dose is missed and it is less than 12 hours until the next dose, the missed dose should beskipped and the next dose taken at the usual time.
2.3 Patients with Renal Impairment
No dose adjustment is needed in patients with an estimated glomerular filtration rate (eGFR) greater thanor 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 [seeCONTRAINDICATIONS (4) and USE IN SPECIFIC POPULATIONS (8.6)].
2.4 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, andtelithromycin) [see DRUG INTERACTIONS (7)].
2.5 Discontinuation for Iodinated Contrast Imaging Procedures
Discontinue QTERNMET XR at the time of, or prior to, an iodinated contrast imaging procedure inpatients with a history of liver disease, alcoholism or heart failure, or in patients who will be administeredintra-arterial iodinated contrast. Re-eva luate eGFR 48 hours after the imaging procedure; restartQTERNMET XR if renal function is stable [see WARNINGS AND PRECAUTIONS (5.1)].
3 DOSAGE FORMS AND STRENGTHS
Extended-Release Tablets:
Dapagliflozin
Strength
Saxagliptin
Strength
Metformin HCl
Strength
Color/Shape Tablet
Identifiers*
2.5 mg 2.5 mg 1000 mg light brown to brown,
biconvex, oval, film-coated
tablet
3001
5 mg 2.5 mg 1000 mg green, biconvex, oval, filmcoated
tablet
3002
5 mg 5 mg 1000 mg pink, biconvex, oval, filmcoated
tablet
3003
10 mg 5 mg 1000 mg gray, biconvex, oval, filmcoated
tablet
3004
* Debossed on one side.
4 CONTRAINDICATIONS
QTERNMET XR is contraindicated in patients with:
•History of a serious hypersensitivity reaction to dapagliflozin, saxagliptin, or metformin, includinganaphylaxis, angioedema, or exfoliative skin conditions [see WARNINGS AND PRECAUTIONS(5.10) 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)].
•Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabeticketoacidosis should be treated with insulin [see WARNINGS AND PRECAUTIONS (5.1) andADVERSE REACTIONS (6.1)].
5 WARNINGS AND PRECAUTIONS
5.1 Lactic Acidosis
There have been post-marketing cases of metformin-associated lac |
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