Glyxambi

— THERAPEUTIC CATEGORIES —
  • Diabetes

Glyxambi Generic Name & Formulations

General Description

Empagliflozin, linagliptin; 10mg/5mg, 25mg/5mg; tabs.

Pharmacological Class

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

How Supplied

Tabs—30, 90

Generic Availability

NO

Glyxambi Indications

Indications

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.

Glyxambi Dosage and Administration

Adult

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

<18yrs: not established.

Glyxambi Contraindications

Contraindications

Patients on dialysis.

Glyxambi Boxed Warnings

Not Applicable

Glyxambi Warnings/Precautions

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 Pharmacokinetics

See Literature

Glyxambi Interactions

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.

Glyxambi Adverse Reactions

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.

Glyxambi Clinical Trials

See Literature

Glyxambi Note

Not Applicable

Glyxambi Patient Counseling

See Literature