GLYXAMBI®
Side effects and safety
FOR ADULTS WITH TYPE 2 DIABETES1
Demonstrated safety profile evaluated over 52 weeks
The safety of concomitantly administered empagliflozin (daily dose 25 mg) and linagliptin (daily dose 5 mg) has been evaluated in patients with type 2 diabetes treated for up to 52 weeks in active-controlled clinical trials.1
Incidence of overall* and severe† hypoglycemic events—through Week 52 in patients uncontrolled on metformin.1
| Add-on to metformin | |
|---|---|
| GLYXAMBI® 25/5 mg (N=137) | |
| Overall (%) | 3.6% |
| Severe (%) | 0% |
| ADVERSE REACTIONS REPORTED IN ≥5% OF PATIENTS TREATED WITH GLYXAMBI®1 | |
| GLYXAMBI® 25/5 mg (N=273) | |
| Urinary tract infection (UTI)‡ | 11.4% |
| Nasopharyngitis | 6.6% |
| Upper respiratory tract infection | 7.0% |
Footnotes:
-
* Overall hypoglycemic events: plasma or capillary glucose ≤70 mg/dL or requiring assistance.
-
† Severe hypoglycemic events: requiring assistance regardless of blood glucose.
-
‡ Predefined adverse event grouping, including, but not limited to, urinary tract infection, asymptomatic bacteriuria, and cystitis.
References:
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GLYXAMBI® approved package insert. Updated in May 2020. Approved in September 2020.
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