HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useQTERNMET XR safely and effectively. See full prescribing informationfor QTERNMET XR.
QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets, for oral use
Initial U.S. Approval: 2019
WARNING: LACTIC ACIDOSIS
See full prescribing information for complete boxed warning.
•Postmarketing cases of metformin-associated lactic acidosishave resulted in death, hypothermia, hypotension, and resistantbradyarrhythmias. Symptoms included malaise, myalgias,respiratory distress, somnolence, and abdominal pain.
Laboratory abnormalities included elevated blood lactatelevels, anion gap acidosis, increased lactate/pyruvate ratio; andmetformin plasma levels generally >5 mcg/mL. (5.1)
•Risk factors include renal impairment, concomitant use ofcertain drugs, age >65 years old, radiological studies withcontrast, surgery and other procedures, hypoxic states,excessive alcohol intake, and hepatic impairment. Steps toreduce the risk of and manage metformin-associated lacticacidosis in these high-risk groups are provided in the FullPrescribing Information. (5.1)
•If lactic acidosis is suspected, discontinue QTERNMET XR andinstitute general supportive measures in a hospital setting.
Prompt hemodialysis is recommended. (5.1)
INDICATIONS AND USAGE
QTERNMET XR is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, adipeptidyl peptidase-4 (DPP-4) inhibitor and a biguanide combination productindicated as an adjunct to diet and exercise to improve glycemic control inadults with type 2 diabetes mellitus. (1)
Limitations of Use
•Is not indicated for the treatment of type 1 diabetes mellitus or diabeticketoacidosis. (1)
•QTERNMET XR initiation is intended only for patients currently takingmetformin. (1)
DOSAGE AND ADMINISTRATION
•Assess renal function before initiation of therapy and periodicallythereafter. (2.1)
•Individualize the starting total daily dose of QTERNMET XR based on thepatient’s current regimen, effectiveness, and tolerability. (2.2)
•Take QTERNMET XR orally, once daily in the morning with food. (2.2)
•For patients not currently taking dapagliflozin, the recommended startingtotal daily dose of QTERNMET XR is a 5 mg dapagliflozin/5 mgsaxagliptin/1000 mg or 2000 mg metformin hydrochloride (HCl) oncedaily. (2.2)
•The maximum recommended daily dose is 10 mg dapagliflozin, 5 mgsaxagliptin and 2000 mg metformin HCl. (2.2)
•Swallow tablet whole. Do not crush, cut or chew. (2.2)
•Discontinue QTERNMET XR at the time of, or prior to, an iodinatedcontrast imaging procedure. (2.5)
DOSAGE FORMS AND STRENGTHS
•Tablet: 2.5 mg dapagliflozin/2.5 mg saxagliptin/1000 mg metformin HClextended-release (3)
•Tablet: 5 mg dapagliflozin/2.5 mg saxagliptin/1000 mg metformin HClextended-release (3)
•Tablet: 5 mg dapagliflozin/5 mg saxagliptin/1000 mg metformin HClextended-release (3)
•Tablet: 10 mg dapagliflozin/5 mg saxagliptin/1000 mg metformin HClextended-release (3)
CONTRAINDICATIONS
•History of a serious hypersensitivity reaction to dapagliflozin, saxagliptin,or metformin, including anaphylaxis, angioedema, or exfoliative skinconditions. (4, 5.9, 6.2)
•Mode