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.
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.
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.
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)
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.
Please see Prescribing Information and Medication Guide.