Empagliflozin / Linagliptin

What it is and how it works

Mechanism of Action GLYXAMBI GLYXAMBI contains: empagliflozin, a SGLT2 inhibitor, and linagliptin, a DPP-4 inhibitor. Empagliflozin Empagliflozin is an inhibitor of SGLT2, the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Linagliptin Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).

Mechanism class: Dipeptidyl Peptidase 4 Inhibitors · Sodium-Glucose Transporter 2 Inhibitors

Indications

is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . Empagliflozin is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease . GLYXAMBI is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease. Limitations of Use Not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients. Has not been studied in patients with a history of pancreatitis.

Dosage and administration (summary)

Assess renal function before initiating and as clinically indicated. Assess volume status and correct volume depletion before initiating. The recommended dosage of GLYXAMBI is 10 mg empagliflozin and 5 mg linagliptin once daily, taken in the morning, with or without food. Dosage may be increased to 25 mg empagliflozin and 5 mg linagliptin once daily. Withhold GLYXAMBI for at least 3 days, if possible, prior to surgery or procedures associated with prolonged fasting. Testing Prior to Initiation of GLYXAMBI Assess renal function before initiating GLYXAMBI and as clinically indicated . Assess volume status. In patients with volume depletion, correct this condition before initiating GLYXAMBI .

Contraindications

is contraindicated in patients: with a hypersensitivity to empagliflozin, linagliptin, or any of the excipients in GLYXAMBI, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred . Hypersensitivity to empagliflozin, linagliptin, or any of the excipients in GLYXAMBI.

Warnings and precautions

Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: Consider ketone monitoring in patients at risk of ketoacidosis, as indicated. Assess for ketoacidosis regardless of presenting blood glucose levels and discontinue GLYXAMBI if ketoacidosis is suspected. Monitor patients for resolution of ketoacidosis before restarting. Pancreatitis: There have been reports of acute pancreatitis, including fatal pancreatitis. If pancreatitis is suspected, promptly discontinue GLYXAMBI.

Pregnancy

Pregnancy Risk Summary Based on animal data showing adverse renal effects from empagliflozin, GLYXAMBI is not recommended during the second and third trimesters of pregnancy. The limited available data with GLYXAMBI, linagliptin, or empagliflozin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and mi…

Storage and supply

Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

Source: Empagliflozin And Linagliptin (Glyxambi) — US FDA prescribing information, 2026-01-20, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.