See Supplemental Patient Information
- Hypotension: Symptomatic hypotension may occur after initiating empagliflozin therapy due to intravascular volume contraction especially in patients with renal impairment, the elderly, in patients with low systolic blood pressure or those on diuretics. Correct volume status if indicated prior to initiating therapy and monitor for signs and symptoms of hypotension
- Ketoacidosis: In postmarketing surveillance, ketoacidosis associated with empagliflozin treatment has been reported. Patients presenting with signs and symptoms of dehydration and severe metabolic acidosis (nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath) should be assessed for ketoacidosis regardless of presenting blood glucose levels. Consider the predisposing factors for ketoacidosis prior to initiating therapy. Discontinue therapy temporarily in clinical situations which are known to predispose to ketoacidosis such as prolonged fasting due to acute illness or surgery
- Empagliflozin is not indicated for T1D
- Renal function impairment: Empagliflozin increases serum creatinine and decreases eGFR. Elderly patients and those with moderate renal impairment are at a greater risk of impaired renal function. Frequent monitoring is recommended. Evaluate renal function before initiating empagliflozin and periodically thereafter
- Urosepsis and pyelonephritis: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections (UTIs) including urosepsis and pyelonephritis. Evaluate patients for signs and symptoms of UTIs and treat promptly, if indicated
- Hypoglycemia with concomitant insulin and insulin secretagogues use: Risk of hypoglycemia may increase when empagliflozin is used in combination with insulin secretagogues (e.g. sulfonylurea) or insulin. Lower the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia
- Genital mycotic infections: Empagliflozin may increase the risk for genital mycotic infections. Monitor and treat as appropriate
- Increased LDL-C levels: Empagliflozin may increase LDL-C levels. Monitor and treat as appropriate
- Avoid using urine glucose test to monitor glycemic control because SGLT2 inhibitors increase urinary glucose excretion. Use alternative methods to monitor glycemic control
- Monitoring glycemic control using 1,5-anhydroglucitol (1,5-AG) assay is not recommended in patients using SGLT2 inhibitors
Cautions: Use cautiously in:
- Renal impairment
- Hypotension
- Hx of genital mycotic infection
- Uncircumcised male patients
- Hx of UTIs
Supplemental Patient Information
- Advise patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical help promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirements may change
- Instruct patients to check ketones if symptoms consistent with ketoacidosis occur even if blood glucose is not elevated
Pregnancy Category:C
Breastfeeding: Safety unknown. It is not known whether empagliflozin is excreted in human breast milk, however, as many drugs are excreted in breast milk and because of the potential for serious adverse reactions in nursing infants, manufacturer advises to make a decision whether to discontinue nursing while taking the drug or to discontinue therapy while nursing, taking into account the importance of the drug to the mother.
45 mL/min/1.73 m2: No dosage adjustment
