TRADJENTA - linagliptin tablet, film coated
Boehringer Ingelheim Pharmaceuticals, Inc.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use TRADJENTA safely and effectively. See full prescribing information for TRADJENTA.
Tradjenta™ (linagliptin) tablets
Initial U.S. Approval: 2011
INDICATIONS AND USAGE
TRADJENTA 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 (1.1)
Important limitations of use:
Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (1.2)
Has not been studied in combination with insulin (1.2)
DOSAGE AND ADMINISTRATION
The recommended dose of TRADJENTA is 5 mg once daily. TRADJENTA can be taken with or without food. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg (3)
CONTRAINDICATIONS
History of hypersensitivity reaction to linagliptin, such as urticaria, angioedema, or bronchial hyperreactivity (4)
WARNINGS AND PRECAUTIONS
When used with an insulin secretagogue (e.g., sulfonylurea), consider lowering the dose of the insulin secretagogue to reduce the risk of hypoglycemia (5.1)
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with TRADJENTA or any other antidiabetic drug (5.2)
ADVERSE REACTIONS
Adverse reactions reported in ≥5% of patients treated with TRADJENTA and more commonly than in patients treated with placebo included nasopharyngitis (6.1)
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 (6.1)
Pancreatitis was reported more often in patients randomized to linagliptin (1 per 538 person years versus zero in 433 person years for comparator) (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or 1-800-459-9906 TTY, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
P-glycoprotein/CYP 3A4 inducer: The efficacy of TRADJENTA may be reduced when administered in combination (e.g., with rifampin). Use of alternative treatments is strongly recommended. (7.1)
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no adequate and well-controlled studies in pregnant women. TRADJENTA tablets should be used during pregnancy only if clearly needed. (8.1)
Nursing mothers: Caution should be exercised when TRADJENTA is administered to a nursing woman (8.3)
Pediatric patients: Safety and effectiveness of TRADJENTA in patients below the age of 18 have not been established (8.4)
Renal or hepatic impairment: No dose adjustment recommended (8.6, 8.7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 05/2011
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
1.1 Monotherapy and Combination Therapy
1.2 Important Limitations of Use
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