QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets(八)
s at a higher riskof heart failure. Observe patients for signs and symptoms of heart failure during therapy. Advise patientsof the characteristic symptoms of heart failure and to immediately report such symptoms. If heart failure develops, eva luate and manage according to current standards of care and consider discontinuation ofQTERNMET XR.
5.4 Hypotension
Dapagliflozin causes intravascular volume contraction. Symptomatic hypotension can occur afterinitiating QTERNMET XR [see ADVERSE REACTIONS (6.1)] particularly in patients with impairedrenal function (eGFR <60 mL/min/1.73 m2), elderly patients or patients on loop diuretics. Beforeinitiating QTERNMET XR, volume status should be assessed and corrected. QTERNMET XR iscontraindicated in patients with an eGFR <45 mL/min/1.73 m2. Monitor for signs and symptoms ofhypotension after initiating therapy.
5.5 Ketoacidosis
Reports of ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, have beenidentified in postmarketing surveillance in patients with type 1 and type 2 diabetes mellitus receivingsodium glucose cotransporter-2 (SGLT2) inhibitors, including dapagliflozin. Fatal cases of ketoacidosishave been reported in patients taking dapagliflozin. QTERNMET XR is not indicated for the treatment ofpatients with type 1 diabetes mellitus [see INDICATIONS AND USAGE (1)].
Patients treated with QTERNMET XR who present with signs and symptoms consistent with severemetabolic acidosis should be assessed for ketoacidosis regardless of presenting blood glucose levels asketoacidosis associated with QTERNMET XR may be present even if blood glucose levels are less than250 mg/dL. If ketoacidosis is suspected, QTERNMET XR should be discontinued, the patient should beeva luated and prompt treatment should be instituted. Treatment of ketoacidosis may require insulin, fluidand carbohydrate replacement.
In many of the postmarketing reports for dapagliflozin, and particularly in patients with type 1 diabetes,the presence of ketoacidosis was not immediately recognized and the institution of treatment was delayedbecause the presenting blood glucose levels were below those typically expected for diabetic ketoacidosis(often less than 250 mg/dL). Signs and symptoms at presentation were consistent with dehydration andsevere metabolic acidosis and included nausea, vomiting, abdominal pain, generalized malaise, andshortness of breath. In some but not all cases, factors predisposing to ketoacidosis such as insulin dosereduction, acute febrile illness, reduced caloric intake due to illness or surgery, pancreatic disorderssuggesting insulin deficiency (e.g., type 1 diabetes, history of pancreatitis or pancreatic surgery), and
alcohol abuse were identified.
Before initiating QTERNMET XR, consider factors in the patient history that may predispose toketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction and alcohol abuse.
In patients treated with QTERNMET XR consider monitoring for ketoacidosis and temporarilydiscontinuing QTERNMET XR in clinical situations known to predispose to ketoacidosis (e.g., prolongedfasting due to acute illness or surgery) [see ADVERSE REACTIONS (6.2)].
5.6 Acute Kidney Injury and Impairment in Renal Function
Dapagliflozin causes intravascular volume contraction [see WARNINGS AND PRECAUTIONS (5.4)] andcan cause renal impairment [see ADVERSE REACTIONS ( |
