Recommended Dosage

The recommended dose of GLYXAMBI is 10 mg empagliflozin/5 mg linagliptin once daily in the morning, taken with or without food. In patients tolerating GLYXAMBI, the dose may be increased to 25 mg empagliflozin/5 mg linagliptin once daily.

In patients with volume depletion, correcting this condition prior to initiation of GLYXAMBI is recommended [see Warnings and Precautions (5.3), Use in Specific Populations (8.5) and Patient Counseling Information (17)].

No studies have been performed specifically examining the safety and efficacy of GLYXAMBI in patients previously treated with other oral antihyperglycemic agents and switched to GLYXAMBI. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.

Patients with Renal Impairment

Assessment of renal function is recommended prior to initiation of GLYXAMBI and periodically thereafter.

GLYXAMBI should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m2.

No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73 m2.

GLYXAMBI should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m2 [see Warnings and Precautions (5.3, 5.5) and Use in Specific Populations (8.6)].