Indications for: GLYXAMBI

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM).

Limitations of Use:

Not recommended in those with type 1 diabetes; may increase risk of diabetic ketoacidosis. Not studied in patients with a history of pancreatitis. Not recommended in adults with T2DM with an eGFR <30mL/min/1.73m2.

Adult Dosage:

Take in the AM. Initially 10mg/5mg once daily; may increase to 25mg/5mg once daily for additional control. Renal impairment: not recommended if eGFR <30mL/min/1.73m2.

Children Dosage:

<18yrs: not established.

GLYXAMBI Contraindications:

Patients on dialysis.

GLYXAMBI Warnings/Precautions:

Correct volume depletion before initiating. Increased risk for volume depletion or hypotension in those with renal impairment (eGFR <60mL/min/1.73m2), elderly, or on loop diuretics. Assess volume status and renal function prior to initiation; monitor during therapy. 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). Consider temporarily discontinuing prior to scheduled surgery (for ≥3 days) or other clinical situations (eg, prolonged fasting due to illness or post-surgery). Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections or UTIs (including urosepsis, pyelonephritis); monitor and treat as appropriate. Monitor for signs/symptoms of pancreatitis, serious hypersensitivity reactions, severe joint pain, or bullous pemphigoid; discontinue if suspected or occurs. History of angioedema to other DPP-4 inhibitors. Known risk factors for heart failure; monitor for signs/symptoms; evaluate and consider discontinuing if develops. Elderly. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.

GLYXAMBI Classification:

Sodium-glucose co-transporter 2 (SGLT2) inhibitor + dipeptidyl peptidase-4 (DPP-4) inhibitor.

GLYXAMBI Interactions:

Greater potential for volume depletion with concomitant diuretics. May need lower doses of the concomitant insulin secretagogue (eg, sulfonylurea) or insulin to reduce risk of hypoglycemia. Antagonized by strong P-gp or CYP3A4 inducers (eg, rifampin); consider alternatives to linagliptin if used in combination. Empagliflozin may antagonize serum lithium concentrations; monitor levels more frequently. Empagliflozin will lead to false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.

Adverse Reactions:

UTIs, nasopharyngitis, upper RTIs, increases in cholesterol and hematocrit; female genital mycotic infections, hypersensitivity reactions, pancreatitis, ketoacidosis, renal impairment, possible severe and disabling arthralgia, bullous pemphigoid; rare: Fournier's gangrene.

Generic Drug Availability:


How Supplied:

Tabs—30, 90