Label Changes for:
Glyxambi (empagliflozin and linagliptin)
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Ketoacidosis (addition of the following sentence in first paragraph)
- Fatal cases of ketoacidosis have been reported in patients taking empagliflozin.
Clinical Trials Experience
- Thirst (including polydipsia) was reported in 0%, 1.7%, and 1.5% for placebo, empagliflozin 10 mg, and empagliflozin 25 mg, respectively.
PATIENT COUNSELING INFORMATION
Ketoacidosis (updated sentences)
- Inform patients that ketoacidosis is a serious life-threatening condition. Cases of ketoacidosis have been reported during use of empagliflozin.
What are the possible side effects of GLYXAMBI?
GLYXAMBI may cause serious side effects, including:
- See “What is the most important information I should know about GLYXAMBI?”
- Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis may lead to death. (addition of sentence).