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Label Changes for:

Tradjenta (linagliptin) tablets, 5 mg

September 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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


September 2012


6.1 Clinical Trial Experience
  • added .... information on Trial Number 1218.20, entitled “A Randomised, Double-blind, Active-controlled Parallel Group Efficacy and Safety Study of Linagliptin (5 mg, Administered Orally Once Daily) Compared to Glimepiride (1 to 4 mg Once Daily) Over Two Years, in Type 2 Diabetic Patients with Insufficient Glycaemic Control Despite Metformin Therapy”


7.1 Inducers of P-glycoprotein or CYP3A4 Enzymes
  • Rifampin decreased linagliptin exposure suggesting that the efficacy of TRADJENTA may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Therefore, use of alternative treatments is strongly recommended when linagliptin is to be administered with a strong P-gp or CYP3A4 inducer [see Clinical Pharmacology (12.3)]. 


August 2012



Use with Medications Known to Cause Hypoglycemia
  • Insulin secretagogues and insulin are known to cause hypoglycemia. The use of Tradjenta in combination with an insulin secretagogue (e.g., sulfonylurea) was associated with a higher rate of hypoglycemia compared with placebo in a clinical trial…