Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- …mouth ulceration…
WARNINGS AND PRECAUTIONS
- There have been postmarketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking Tradjenta. Take careful notice of potential signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue Tradjenta and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Tradjenta.
- Acute pancreatitis, including fatal pancreatitis
PATIENT COUNSELING INFORMATION
- Inform patients that acute pancreatitis has been reported during postmarketing use of Tradjenta.. Inform patients that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue Tradjenta promptly and contact their physician if persistent severe abdominal pain occurs.
6 ADVERSE REACTIONS
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 DRUG INTERACTIONS
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)].
WARNINGS AND PRECAUTIONS
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…
- Adverse reactions of hypoglycemia were based on all reports of hypoglycemia. A concurrent glucose measurement was not required or was normal in some patients. Therefore, it is not possible to conclusively determine that all these reports reflect true hypoglycemia.
- In the study of patients receiving Tradjenta as add-on therapy to a stable dose of insulin for up to 52 weeks (n=1261), no significant difference in the incidence of investigator reported hypoglycemia, defined as all symptomatic or asymptomatic episodes with a self measured blood glucose ≤ 70mg/dL, was noted between the Tradjenta (31.4%) and placebo (32.9%) treated groups…
Use in Renal Impairment
- Tradjenta was compared to placebo as add-on to pre-existing antidiabetic therapy over 52 weeks in 133 patients with severe renal impairment (estimated GFR <30ml/min)…