QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets(七)
ated contrast agents inmetformin-treated patients has led to an acute decrease in renal function and the occurrence of lacticacidosis. Stop QTERNMET XR at the time of, or prior to, an iodinated contrast imaging procedure inpatients with a history of hepatic impairment, alcoholism, or heart failure; or in patients who will beadministered intra-arterial iodinated contrast. Re-eva luate eGFR 48 hours after the imaging procedure,and restart QTERNMET XR if renal function is stable.
Surgery and Other Procedures: Withholding of food and fluids during surgical or other procedures mayincrease the risk for volume depletion, hypotension and renal impairment. QTERNMET XR should betemporarily discontinued while patients have restricted food and fluid intake.
Hypoxic States: Several of the postmarketing cases of metformin-associated lactic acidosis occurred inthe setting of acute congestive heart failure (particularly when accompanied by hypoperfusion andhypoxemia). Cardiovascular collapse (shock), acute myocardial infarction, sepsis and other conditionsassociated with hypoxemia have been associated with lactic acidosis and may also cause prerenalazotemia. When such events occur, discontinue QTERNMET XR.
Excessive Alcohol Intake: Alcohol potentiates the effect of metformin on lactate metabolism and this mayincrease the risk of metformin-associated lactic acidosis. Warn patients against excessive alcohol intakewhile receiving QTERNMET XR.
Hepatic Impairment: Patients with hepatic impairment have developed with cases of metforminassociatedlactic acidosis. This may be due to impaired lactate clearance resulting in higher lactate bloodlevels. Therefore, avoid use of QTERNMET XR in patients with clinical or laboratory evidence ofhepatic disease.
5.2 Pancreatitis
There have been postmarketing reports of acute pancreatitis in patients taking saxagliptin. In acardiovascular outcomes trial enrolling participants with established atherosclerotic cardiovasculardisease (ASCVD) or multiple risk factors for ASCVD (SAVOR trial), cases of definite acute pancreatitiswere 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 thosepatients receiving saxagliptin and in 100% (9/9) of those patients receiving placebo.
After initiation of QTERNMET XR, observe patients for signs and symptoms of pancreatitis.
Ifpancreatitis is suspected, promptly discontinue QTERNMET XR and initiate appropriate management.
Itis unknown whether patients with a history of pancreatitis are at increased risk for the development of
pancreatitis while using QTERNMET XR.
5.3 Heart Failure
In a cardiovascular outcomes trial enrolling participants with established ASCVD or multiple risk factorsfor ASCVD (SAVOR trial), more patients randomized to saxagliptin (289/8280, 3.5%) were hospitalizedfor heart failure compared to patients randomized to placebo (228/8212, 2.8%). In a time-to-first-eventanalysis, the risk of hospitalization for heart failure was higher in the saxagliptin group (estimated HazardRatio: 1.27; 95% CI: 1.07, 1.51). Subjects with a prior history of heart failure and subjects with renalimpairment had a higher risk for hospitalization for heart failure, irrespective of treatment assignment.
Consider the risks and benefits of QTERNMET XR prior to initiating treatment in patient |
