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Label Changes for:

Glyxambi (empagliflozin and linagliptin) 

July 2016

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)

July 2016

WARNINGS AND PRECAUTIONS

Ketoacidosis (addition of the following sentence in first paragraph)
  • Fatal cases of ketoacidosis have been reported in patients taking empagliflozin.

ADVERSE REACTIONS

Clinical Trials Experience

Empagliflozin

  • 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.

MEDICATION GUIDE

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).
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