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About TRADJENTATreatment with TRADJENTA produced clinically significant improvements in A1C compared with placebo in approximately 3800 patients across 8 clinical trialsTRADJENTA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.In clinical trials, TRADJENTA has been shown to provide significant improvement in A1C as monotherapy and in combination.Clinical study results showed renal excretion <5% of the administered dose. Dosage and administration: one daily dose with no dosage adjustment recommended for patients with renal or hepatic impairment.Indication and Important Limitations of UseTRADJENTA 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 combination with insulin. Important Safety InformationCONTRAINDICATIONSTRADJENTA is contraindicated in patients with a history of hypersensitivity reaction to linagliptin, such as urticaria, angioedema or bronchial hyperreactivity.WARNINGS AND PRECAUTIONSUse with Medications Known to Cause HypoglycemiaInsulin secretagogues (e.g., sulfonylurea) are known to cause hypoglycemia. Therefore, a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with TRADJENTA.Macrovascular OutcomesThere have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with TRADJENTA or any other antidiabetic drug.ADVERSE REACTIONSAdverse reactions reported in ��% of patients treated with TRADJENTA and more commonly than in patients treated with placebo included nasopharyngitis. Hypoglycemia was more commonly reported in patients treated with the combination of TRADJENTA and sulfonylurea compared with those treated with the combination of placebo and sulfonylurea. Pancreatitis was reported more often in patients randomized to linagliptin (1 per 538 person-years versus zero in 433 person-years for comparator). DRUG INTERACTIONSThe efficacy of TRADJENTA may be reduced when administered in combination with a strong P-glycoprotein or CYP3A4 inducer (e.g., rifampin). Therefore, use of alternative treatments is strongly recommended.USE IN SPECIFIC POPULATIONS
There are no adequate and well-controlled studies in pregnant women. Therefore, TRADJENTA should be used during pregnancy only if clearly needed. It is not known whether linagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRADJENTA is administered to a nursing woman. Safety and effectiveness of TRADJENTA in patients below the age of 18 have not been established.
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