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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, for oral use
Initial U.S. Approval: 2011
----------------------------RECENT MAJOR CHANGES-------------------------Warnings and Precautions
Heart Failure (5.2)
8/2017
Bullous Pemphigoid (5.6)
12/2016
----------------------------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 patients with a history of pancreatitis (1.2)
----------------------DOSAGE AND ADMINISTRATION----------------------
The recommended dose of TRADJENTA is 5 mg once daily. (2.1)

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 anaphylaxis,
angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity
(4)
-----------------------WARNINGS AND PRECAUTIONS-----------------------
There have been postmarketing reports of acute pancreatitis, including
fatal pancreatitis. If pancreatitis is suspected, promptly discontinue
TRADJENTA. (5.1)

Heart failure has been observed with two other members of the DPP-4
inhibitor class. Consider risks and benefits of TRADJENTA in patients





who have known risk factors for heart failure. Monitor for signs and
symptoms. (5.2)
When used with an insulin secretagogue (e.g., sulfonylurea) or insulin,
consider lowering the dose of the insulin secretagogue or insulin to
reduce the risk of hypoglycemia (5.3)
There have been postmarketing reports of serious hypersensitivity
reactions in patients treated with TRADJENTA including anaphylaxis,
angioedema, and exfoliative skin conditions. In such cases, promptly
discontinue TRADJENTA, assess for other potential causes, institute
appropriate monitoring and treatment, and initiate alternative treatment
for diabetes. (5.4)
Severe and disabling arthralgia has been reported in patients taking
DPP-4 inhibitors. Consider as a possible cause for severe joint pain and
discontinue drug if appropriate. (5.5)
There have been postmarketing 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. (5.6)
There have been no clinical studies establishing conclusive evidence of
macrovascular risk reduction with TRADJENTA (5.7)
------------------------------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)
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------------------------------Strong P-glycoprotein/CYP3A4 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)
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 8/2017
_______________________________________________________________________________________________________________________________________
FULL PRESCRIBING INFORMATION: CONTENTS*
1
2
3
4
5
6
7
INDICATIONS AND USAGE
1.1 Monotherapy and Combination Therapy
1.2 Important Limitations of Use
DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing
2.2 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea)
or with Insulin
DOSAGE FORMS AND STRENGTHS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
5.1 Pancreatitis
5.2 Heart Failure
5.3 Use with Medications Known to Cause Hypoglycemia
5.4 Hypersensitivity Reactions