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IN ADDITION TO DIET AND EXERCISE, TO IMPROVE GLYCEMIC CONTROL IN ADULT PATIENTS WITH TYPE 2 DIABETES. NOT FOR TYPE 1 DIABETES.

TRADJENTA does not need to be dose adjusted, regardless of renal function*,1.

* One 5-mg tablet, once daily in adult patients with type 2 diabetes.

When TRADJENTA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.

Learn more about dosing
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In addition to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. Not for type 1 diabetes.

TRADJENTA has safety data from two separate CV outcome trials2,3.

Review the CVOT data
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In addition to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. Not for type 1 diabetes.

Learn more about A1C reductions in adult patients with T2DM.

Assess the A1C reduction data
Abbreviations

DPP-4i: dipeptidyl peptidase-4 inhibitor; T2DM: type 2 diabetes mellitus 

References
  1. TRADJENTA Prescribing Information, Boehringer Ingelheim Pharmaceuticals, Inc.
  2. Rosenstock J, Perkovic V, Johansen OE, et al; CARMELINA Investigators. Effect of linagliptin vs placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk: the CARMELINA randomized clinical trial. JAMA. 2019;321(1):69-79.
  3. Rosenstock J, Kahn SE, Johansen OE, et al. Effect of linagliptin vs glimepiride on major adverse cardiovascular outcomes in patients with type 2 diabetes: The CAROLINA randomized clinical trial. JAMA. 2019 Sep 19;322(12):1155-1166.
  4. Del Prato S, Barnett AH, Huisman H, et al. Effect of linagliptin monotherapy on glycaemic control and markers of β-cell function in patients with inadequately controlled type 2 diabetes: a randomized controlled trial. Diabetes Obes Metab. 2011;13(3):258-267.
  5. Taskinen MR, Rosenstock J, Tamminen I, et al. Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab. 2011;13(1):65-74.
INDICATION AND LIMITATIONS OF USE

TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

TRADJENTA is not recommended in patients with type 1 diabetes mellitus.

TRADJENTA has not been studied in patients with a history of pancreatitis, and it is unknown if using TRADJENTA increases the risk of developing pancreatitis in these patients.

 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: Hypersensitivity to linagliptin or any of the excipients in TRADJENTA, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred.

WARNINGS AND PRECAUTIONS

Pancreatitis: Acute pancreatitis, including fatal pancreatitis, has been reported in patients taking TRADJENTA. Take careful notice of potential signs and symptoms of pancreatitis and, if suspected, promptly discontinue 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.

Hypoglycemia: The use in combination with insulin or insulin secretagogues increases the risk of hypoglycemia. A lower dosage of insulin or insulin secretagogue may be required.

Hypersensitivity Reactions: Discontinue TRADJENTA, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes mellitus. Use caution in a patient with a history of angioedema to another DPP-4 inhibitor because it is unknown whether such patients will be predisposed to angioedema with TRADJENTA.

Severe and Disabling Arthralgia: Severe and disabling arthralgia has been reported in patients taking TRADJENTA. Consider TRADJENTA as a possible cause for severe joint pain and/or disabling arthralgia and discontinue, if appropriate.

Bullous Pemphigoid: There have been reports of bullous pemphigoid requiring hospitalization. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue TRADJENTA.

Heart Failure: Heart failure has been observed with two other members of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. Consider the risks and benefits of TRADJENTA in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment. Monitor patients for signs and symptoms. Advise patients of the symptoms of heart failure and to immediately report such symptoms. If heart failure develops consider discontinuation of TRADJENTA.

MOST COMMON ADVERSE REACTIONS (≥5%): Nasopharyngitis, hypoglycemia (when used in combination with sulfonylurea).

DRUG INTERACTIONS: The efficacy of TRADJENTA may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Alternative treatments should be used.

USE IN SPECIFIC POPULATIONS: Use during pregnancy only if clearly needed. Exercise caution when administering to a nursing woman.

CL-TJ-100060 06.16.2023

Please see Prescribing Information, including Medication Guide.