SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(七)
ype 1 diabetes mellitus [see INDICATIONS AND USAGE (1)].
Patients treated with SYNJARDY XR who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of presenting blood glucose levels, as ketoacidosis associated with SYNJARDY XR may be present even if blood glucose levels are less than 250 mg/dL. If ketoacidosis is suspected, SYNJARDY XR should be discontinued, patient should be eva luated, and prompt treatment should be instituted. Treatment of ketoacidosis may require insulin, fluid and carbohydrate replacement.
In many of the postmarketing reports, and particularly in patients with type 1 diabetes, the presence of ketoacidosis was not immediately recognized and institution of treatment was delayed because 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 and severe metabolic acidosis and included nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. In some but not all cases, factors predisposing to ketoacidosis such as insulin dose reduction, acute febrile illness, reduced caloric intake due to illness or surgery, pancreatic disorders suggesting insulin deficiency (e.g., type 1 diabetes, history of pancreatitis or pancreatic surgery), and alcohol abuse were identified.
Before initiating SYNJARDY XR, consider factors in the patient history that may predispose to ketoacidosis including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse. In patients treated with SYNJARDY XR consider monitoring for ketoacidosis and temporarily discontinuing SYNJARDY XR in clinical situations known to predispose to ketoacidosis (e.g., prolonged fasting due to acute illness or surgery).
5.4 Acute Kidney Injury and Impairment in Renal Function
Empagliflozin causes intravascular volume contraction [see WARNINGS AND PRECAUTIONS (5.2)] and can cause renal impairment [see ADVERSE REACTIONS (6.1)]. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving SGLT2 inhibitors, including empagliflozin; some reports involved patients younger than 65 years of age.
Before initiating SYNJARDY XR, consider factors that may predispose patients to acute kidney injury including hypovolemia, chronic renal insufficiency, congestive heart failure and concomitant medications (diuretics, ACE inhibitors, ARBs, NSAIDs). Consider temporarily discontinuing SYNJARDY XR in any setting of reduced oral intake (such as acute illness or fasting) or fluid losses (such as gastrointestinal illness or excessive heat exposure); monitor patients for signs and symptoms of acute kidney injury. If acute kidney injury occurs, discontinue SYNJARDY XR promptly and institute treatment.
Empagliflozin increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Renal function abnormalities can occur after initiating SYNJARDY XR [see ADVERSE REACTIONS (6.1)]. Renal function should be eva luated prior to initiation of SYNJARDY XR and monitored periodically thereafter. More frequent renal function monitoring is recommended in patients with an eGFR below 60 mL/min/1.73 m2. Use of SYNJARDY XR is contraindicated in patients with an eGFR less than 45 mL/min/1.73 m2 [see DOS |
