QTERNMET XR(dapagliflozin, saxagliptin, and metforminhydrochloride)extended-release tablets(三十五)
reatitis has been reported during postmarketing use of saxagliptin.
Inform patients that persistent severe abdominal pain, sometimes radiating to the back, which may ormay not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis [see WARNINGSAND PRECAUTIONS (5.2)].
•Instruct patients to promptly discontinue QTERNMET XR and contact their healthcare provider ifpersistent severe abdominal pain occurs.
Heart Failure
•Inform patients of the signs and symptoms of heart failure. Instruct patients to contact their healthcareprovider as soon as possible if they experience symptoms of heart failure, including increasingshortness of breath, rapid increase in weight or swelling of the feet [see WARNINGS ANDPRECAUTIONS (5.3)].
Hypotension
•Inform patients that symptomatic hypotension may occur with QTERNMET XR and advise them tocontact their healthcare provider if they experience such symptoms. Inform patients that dehydrationmay increase the risk for hypotension, and to have adequate fluid intake [see WARNINGS ANDPRECAUTIONS (5.4)].
Ketoacidosis
•Inform patients that ketoacidosis is a serious life-threatening condition. Cases of ketoacidosishave been reported during use of dapagliflozin. Instruct patients to check ketones (whenpossible) if symptoms consistent with ketoacidosis occur even if blood glucose is not elevated. Ifsymptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and laboredbreathing) occur, instruct patients to discontinue QTERNMET XR and seek medical adviceimmediately [see WARNINGS AND PRECAUTIONS (5.5)].
Acute Kidney Injury
•Inform patients that acute kidney injury has been reported during use of dapagliflozin. Advise patientsto seek medical advice immediately if they have reduced oral intake (due to acute illness or fasting) orincreased fluid losses (due to vomiting, diarrhea, or excessive heat exposure), as it may be appropriateto temporarily discontinue QTERNMET XR use in those settings [see WARNINGS ANDPRECAUTIONS (5.6)].
Serious Urinary Tract Infections
•Inform patients of the potential for urinary tract infections, which may be serious. Inform them of thesymptoms of urinary tract infections and advise them to seek medical advice if such symptoms occur[see WARNINGS AND PRECAUTIONS (5.7)].
Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)
•Inform patients that necrotizing infections of the perineum (Fournier’s gangrene) have occurred withdapagliflozin, a component of QTERNMET XR. Counsel patients to promptly seek medical attentionif they develop pain or tenderness, redness, or swelling of the genitals or the area from the genitalsback to the rectum, along with a fever above 100.4°F or malaise [see WARNINGS ANDPRECAUTIONS (5.9)].
Hypersensitivity Reactions
•Inform patients that serious hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, andexfoliative skin conditions) have been reported with dapagliflozin and saxagliptin, components ofQTERNMET XR. Symptoms of these allergic reactions include: rash, skin flaking or peeling,urticaria, swelling of the skin, or swelling of the face, lips, tongue, and throat that may causedifficulty in breathing or swallowing [see WARNINGS AND PRECAUTIONS (5.10)].
•Advise patients to immediately report any signs or symptoms suggesting allergic reaction,angioedema, or |
