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QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets(二)
rate to severe renal impairment (eGFR <45 mL/min/1.73 m2),end-stage renal disease (ESRD), or patients on dialysis. (4)
•Acute or chronic metabolic acidosis, including diabetic ketoacidosis, withor without coma. Diabetic ketoacidosis should be treated with insulin. (4)
USE IN SPECIFIC POPULATIONS
Pregnancy: Advise females of the potential risk to a fetus especially duringthe second and third trimesters. (8.1)
Lactation: QTERNMET XR is not recommended when breastfeeding. (8.2)
Females and Males of Reproductive Potential: Advise premenopausal femalesof the potential for an unintended pregnancy. (8.3)
Geriatrics: Higher incidence of adverse reactions related to volume depletionand reduced renal function. (5.4, 5.6, 8.5)
WARNINGS AND PRECAUTIONS
Lactic acidosis: See boxed warning (2.2, 4, 5.1)
Pancreatitis: If pancreatitis is suspected, promptly discontinue. (5.2, 6.2)
Heart Failure: Consider the risks and benefits of QTERNMET XR in patientswho have known risk factors for heart failure. Monitor patients. (5.3)
Hypotension: Before initiating QTERNMET XR, assess volume status andcorrect hypovolemia in the elderly, in patients with renal impairment orlow systolic blood pressure, and in patients on loop diuretics. Monitor forsigns and symptoms during therapy. (5.4, 6.1)
Ketoacidosis: Assess patients who present with signs and symptoms ofmetabolic acidosis for ketoacidosis regardless of blood glucose level. Ifsuspected, discontinue QTERNMET XR, eva luate and treat promptly.
Before initiating QTERNMET XR, consider risk factors for ketoacidosis.
Patients on QTERNMET XR may require monitoring and temporarydiscontinuation of therapy in clinical situations known to predispose toketoacidosis. (5.5, 6.2)
Acute Kidney Injury and Impairment in Renal Function: Consider temporarilydiscontinuing in settings of reduced oral intake or fluid losses. If acutekidney injury occurs, discontinue and promptly treat. Monitor renalfunction during therapy. (5.6, 6.2)
Urosepsis and Pyelonephritis: eva luate for signs and symptoms of urinarytract infections and treat promptly, if indicated. (5.7, 6.2)
Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulinto reduce the risk of hypoglycemia when initiating QTERNMET XR incombination with these agents. (5.8, 6.1)
Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, lifethreateningcases have occurred in both females and males. Assess patientspresenting with pain or tenderness, erythema, or swelling in the genital orperineal area, along with fever or malaise. If suspected, institute prompttreatment. (5.9)
Hypersensitivity Reactions (e.g., urticaria, facial edema): There have beenpostmarketing reports of serious hypersensitivity reactions treated withsaxagliptin, such as anaphylaxis, angioedema, and exfoliative skinconditions. Promptly discontinue QTERNMET XR, assess for otherpotential causes, institute appropriate monitoring and treatment, and initiatealternative treatment for diabetes. (5.10, 6.2)
Vitamin B12 deficiency: Metformin may lower vitamin B12 levels. Measurehematological parameters annually. (5.11, 6.1)
Genital Mycotic Infections: Monitor and treat if indicated. (5.12, 6.1)
Increased LDL-C: Monitor and treat per standard of care. (5.13, 6.1)
Bladder Cancer: An imbalance in bladder cancers was observed in clinicalstudies with dapagliflozin |
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