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Dosing

In addition to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. Not for type 1 diabetes or diabetic ketoacidosis.

We appreciate your interest in the dosing information for TRADJENTA. TRADJENTA is the only single-strength DPP-4 inhibitor that requires no dose adjustment regardless of renal function. Please see below for additional details.

The only single-strength DPP-4i* with no dose adjustment, regardless of renal function

Dosing and Renal Function

*One 5-mg tablet, once daily for adult patients with type 2 diabetes.
Refers to categories of renal impairment.

Primarily nonrenal excretion with 5% elimination via the kidney and 80% excreted via the bile and gut within 4 days of dosing.

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

TRADJENTA DOSING AND ADMINISTRATION

  • The recommended dose of TRADJENTA is 5 mg once daily

  • TRADJENTA can be taken with or without food

 

Get useful information about the formulary coverage for TRADJENTA in your state

 

Explore A1C reductions in adult patients with T2DM and renal impairment

Important Safety Information  

CONTRAINDICATIONS

TRADJENTA is contraindicated in patients with a history of hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity.

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.

Indication and Important 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 should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

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.

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.

Use with Medications Known to Cause Hypoglycemia

The use in combination with insulin or insulin secretagogues (e.g., sulfonylurea) increases the risk of hypoglycemia. A lower dose of insulin or insulin secretagogue may be required.

Hypersensitivity Reactions

Serious hypersensitivity reactions have been reported in patients treated with TRADJENTA including anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment, with some occurring after the first dose. If a serious hypersensitivity reaction is suspected, discontinue, assess for other potential causes for the event, and institute alternative treatment for diabetes.

Angioedema has also been reported with other DPP-4 inhibitors. 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 DPP-4 inhibitors. Consider linagliptin 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 in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue TRADJENTA.

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with 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-100001 8.21.17

Please see Prescribing Information and Medication Guide.

Important Safety Information  

CONTRAINDICATIONS

TRADJENTA is contraindicated in patients with a history of hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity.

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.

Indication and Important 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 should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

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.

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.

Use with Medications Known to Cause Hypoglycemia

The use in combination with insulin or insulin secretagogues (e.g., sulfonylurea) increases the risk of hypoglycemia. A lower dose of insulin or insulin secretagogue may be required.

Hypersensitivity Reactions

Serious hypersensitivity reactions have been reported in patients treated with TRADJENTA including anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment, with some occurring after the first dose. If a serious hypersensitivity reaction is suspected, discontinue, assess for other potential causes for the event, and institute alternative treatment for diabetes.

Angioedema has also been reported with other DPP-4 inhibitors. 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 DPP-4 inhibitors. Consider linagliptin 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 in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue TRADJENTA.

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with 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-100001 8.21.17

Please see Prescribing Information and Medication Guide.