QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets(三十四)
n saxagliptinwith an estimated HR: 1.0; 95.1% CI: (0.89, 1.12). The upper bound of this confidence interval, 1.12,excluded a risk margin larger than 1.3.
Vital status was obtained for 99% of subjects in the trial. There were 798 deaths in the SAVOR trial.
Numerically more patients (5.1%) died in the saxagliptin group than in the placebo group (4.6%). Therisk of deaths from all-cause mortality was not statistically different between the treatment groups(HR: 1.11; 95.1% CI: 0.96, 1.27).
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
QTERNMET XR (dapagliflozin, saxagliptin, and metformin HCl) extended-release tablets are available
in packages as listed:
Tablet Strength
Film-Coated Tablet
Color/Shape
Tablet
Markings Pack Size NDC Code
2.5 mg dapagliflozin
/2.5 mg saxagliptin
/1000 mg metformin HCl
Light brown to brown
biconvex, oval
“3001”
debossed on
one side
Bottles of 60 0310-6925-60
Film-Coated Tablet
Color/Shape
Tablet
Markings Pack Size NDC Code
5 mg dapagliflozin
/2.5 mg saxagliptin
/1000 mg metformin HCl
Green
biconvex, oval
“3002”
debossed on
one side
Bottles of 60 0310-6950-60
5 mg dapagliflozin /5 mg
saxagliptin /1000 mg
metformin HCl
Pink
biconvex, oval
“3003”
debossed on
one side
Bottles of 30 0310-6975-30
10 mg dapagliflozin
/5 mg saxagliptin
/1000 mg metformin HCl
Gray
biconvex, oval
“3004”
debossed on
one side
Bottles of 30 0310-6990-30
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see
USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Lactic Acidosis
•Inform patients of the risks of lactic acidosis due to the metformin component and its symptoms andconditions that predispose to its development [see WARNINGS AND PRECAUTIONS (5.1)].
Advisepatients to discontinue QTERNMET XR immediately and to promptly notify their healthcareprovider if unexplained hyperventilation, myalgia, malaise, unusual somnolence, dizziness, slow orirregular heartbeat, sensation of feeling cold (especially in the extremities), or other nonspecificsymptoms occur. Gastrointestinal symptoms are common during initiation of metformin treatmentand may occur during initiation of QTERNMET XR therapy; however, inform patients to consulttheir physician if they develop unexplained symptoms. Although gastrointestinal symptoms that occurafter stabilization are unlikely to be drug related, such an occurrence of symptoms should beeva luated to determine if it may be due to lactic acidosis or other serious disease.
•Counsel patients against excessive alcohol intake while receiving QTERNMET XR.
•Inform patients about the importance of regular testing of renal function and hematologicalparameters when receiving treatment with QTERNMET XR.
•Instruct patients to inform their healthcare provider that they are taking QTERNMET XR prior to anysurgical or radiological procedure, as temporary discontinuation of QTERNMET XR may be requireduntil renal function has been confirmed to be normal [see WARNINGS AND PRECAUTIONS (5.1)].
Pancreatitis
•Inform patients that acute panc |
