QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets(九)
6.1)]. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving dapagliflozin;some reports involved patients younger than 65 years of age.
Before initiating QTERNMET XR, consider factors that may predispose patients to acute kidney injuryincluding hypovolemia, chronic renal insufficiency, congestive heart failure and concomitant medications(diuretics, ACE inhibitors, ARBs and NSAIDs). Consider temporarily discontinuing QTERNMET XR inany setting of reduced oral intake (such as acute illness or fasting) or fluid losses (gastrointestinal illnessor excessive heat exposure); monitor patients for signs and symptoms of acute kidney injury. If acutekidney injury occurs, discontinue QTERNMET XR promptly and institute treatment.
Dapagliflozin increases serum creatinine and decreases eGFR. Elderly patients and patients with impairedrenal function may be more susceptible to these changes. Adverse reactions related to renal function canoccur after initiating QTERNMET XR [see ADVERSE REACTIONS (6.1)]. Renal function should beeva luated prior to initiation of QTERNMET XR and monitored periodically thereafter. QTERNMET XRis contraindicated in patients with an eGFR less than 45 mL/min/1.73 m2 [see DOSAGE ANDADMINISTRATION (2.2), CONTRAINDICATIONS (4) and USE IN SPECIFIC POPULATIONS (8.6)].
5.7 Urosepsis and Pyelonephritis
There have been postmarketing reports of serious urinary tract infections including urosepsis andpyelonephritis requiring hospitalization in patients receiving SGLT2 inhibitors, including dapagliflozin.
Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. eva luate patients for signsand symptoms of urinary tract infections and treat promptly, if indicated [see ADVERSE REACTIONS(6.2)].
5.8 Hypoglycemia with Concomitant Use of Insulin or Insulin Secretagogues
Insulin and insulin secretagogues, such as sulfonylureas, are known to cause hypoglycemia.
Dapagliflozin, and saxagliptin can individually increase the risk of hypoglycemia when combined withinsulin or an insulin secretagogue. Hypoglycemia does not occur in patients receiving metformin aloneunder usual circumstances of use but could occur during concomitant use with other glucose-loweringagents. Therefore, a lower dose of insulin or insulin secretagogue may be required to reduce the risk ofhypoglycemia when these agents are used in combination with QTERNMET XR [see ADVERSE
REACTIONS (6.1)].
5.9 Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)
Reports of necrotizing fasciitis of the perineum (Fournier’s gangrene), a rare but serious and lifethreateningnecrotizing infection requiring urgent surgical intervention, have been identified inpostmarketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors, includingdapagliflozin. Cases have been reported in females and males. Serious outcomes have includedhospitalization, multiple surgeries, and death.
Patients treated with QTERNMET XR presenting with pain or tenderness, erythema, or swelling in thegenital or perineal area, along with fever or malaise, should be assessed for necrotizing fasciitis. Ifsuspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue QTERNMET XR, closely monitor blood glucose levels, and provideappropriate alt |
