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Tradjenta (linagliptin) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- TRADJENTA is contraindicated in patients with a history of a hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].
5 WARNINGS AND PRECAUTIONS
5.3 Hypersensitivity Reactions
- There have been postmarketing reports of serious hypersensitivity reactions in patients treated with linagliptin (one of the components of JENTADUETO). These reactions include anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment with linagliptin, with some reports occurring after the first dose. If a serious hypersensitivity reaction is suspected, discontinue JENTADUETO, assess for other potential causes for the event, and institute alternative treatment for diabetes.
6 ADVERSE REACTIONS
6.2 Postmarketing Experience
- Hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions [see Warnings and Precautions (5.3)]
17 PATIENT COUNSELING INFORMATION
- Inform patients that serious allergic reactions, such as anaphylaxis, angioedema, and exfoliative skin conditions, have been reported during postmarketing use of linagliptin (one of the components of JENTADUETO). If symptoms of allergic reactions (such as rash, skin flaking or peeling, urticaria, swelling of the skin, or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, patients must stop taking JENTADUETO and seek medical advice promptly.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
- The safety evaluation of linagliptin 5 mg once daily in patient with type 2 diabetes is based on 13 placebo-controlled trials and 1 active-controlled study. In the 13 placebo-controlled studies, a total of 2994 patients were randomized and treated with TRADJENTA 5 mg daily and 1546 with placebo. The mean exposure across studies was 21.4 weeks. The maximum follow-up was 78 weeks.
- NOTE: multiple updated changes to numbers in Table 1 and section 6.1
8 USE IN SPECIFIC POPULATIONS
- These changes are based on the safety and efficacy results from trial 1218.46, entitled “A Phase 3, randomized, double-blind, placebo-controlled parallel group study to compare the efficacy and safety of twice daily administration of the free combination of linagliptin 2.5 mg + metformin 500 mg or of linagliptin 2.5 mg + metformin 1000 mg, with the individual components of metformin (500 mg or 1000 mg, twice daily) and linagliptin (5 mg, once daily) over 24 weeks in drug naive or previously treated (4 weeks washout and 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycemic control.” The efficacy and safety of trial 1218.46 was fully reviewed under the Jentadueto (linagliptin/metformin fixed-dose combination) NDA (201281).