Safety

Lantus (insulin glargine [rDNA origin] injection) solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

July 2015

Summary View

CONTRAINDICATIONS

  • During episodes of hypoglycemia

WARNINGS AND PRECAUTIONS

  • *several content updates to bring content of labeling in line with the current best practices of the Physician’s Labeling Rule.

ADVERSE REACTIONS

  • … Hypokalemia

 

October 2013

Summary View

WARNINGS AND PRECAUTIONS

Fluid retention and heart failure with concomitant use of PPAR-gamma agonists
  • Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including LANTUS, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered. 

Page Last Updated: 08/14/2015
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