Generic Name and Formulations:
Empagliflozin, linagliptin; 10mg/5mg, 25mg/5mg; tabs.
Boehringer Ingelheim and Lilly
Indications for GLYXAMBI:
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both empagliflozin and linagliptin is appropriate.
Limitations Of use:
Not for treating type 1 diabetes or diabetic ketoacidosis. Not studied in patients with a history of pancreatitis.
Take in the AM. Initially 10mg/5mg once daily; may increase to 25mg/5mg once daily if tolerated. Renal impairment: do not initiate if eGFR <45mL/min/1.73m2; discontinue if eGFR falls persistently <45mL/min/1.73m2.
<18yrs: not established.
Severe renal impairment (eGFR <30mL/min/1.73m2), ESRD, or dialysis.
Correct volume depletion and assess for volume contraction before initiating. Monitor for symptomatic hypotension after starting therapy (esp. elderly, renal impairment or low systolic BP, or on diuretics); more frequently if volume contraction expected. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Evaluate renal function prior to starting and monitor periodically thereafter; more frequently if eGFR <60mL/min/1.73m2. Risk of acute kidney injury in hypovolemia, chronic renal insufficiency, CHF, and concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Consider risks/benefits in patients with known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. Monitor for signs/symptoms of pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid; discontinue if suspected or occurs. Monitor for genital mycotic infections, UTIs, increases in LDL-C; treat as appropriate. History of angioedema to other DPP-4 inhibitors. Elderly. Pregnancy (avoid during 2nd & 3rd trimesters). Nursing mothers: not recommended.
Sodium-glucose co-transporter 2 (SGLT2) inhibitor + dipeptidyl peptidase-4 (DPP-4) inhibitor.
Consider a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. Greater potential for volume depletion with concomitant diuretics. Antagonized by strong P-gp or CYP3A4 inducers (eg, rifampin); consider alternatives to linagliptin if used in combination. May result in false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.
UTIs, nasopharyngitis, upper RTIs, increases in cholesterol and hematocrit; female genital mycotic infections, hypersensitivity reactions, pancreatitis, ketoacidosis, renal impairment, urosepsis, pyelonephritis, possible severe and disabling arthralgia, bullous pemphigoid.