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TRADJENTA™ (linagliptin) tablet

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DESCRIPTION CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE CONTRAINDICATIONS
PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED

(DESCRIPTION) top of page

Initial U.S. Approval: 2011
DESCRIPTION
TRADJENTA (linagliptin) tablets contain, as the active ingredient, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme.

Linagliptin is a white to yellowish, not or only slightly hygroscopic solid substance. It is very slightly soluble in water (0.9 mg/mL). Linagliptin is soluble in methanol (ca. 60 mg/mL), sparingly soluble in ethanol (ca. 10 mg/mL), very slightly soluble in isopropanol (<1 mg/mL), and very slightly soluble in acetone (ca. 1 mg/mL).

Each film-coated tablet of TRADJENTA contains 5 mg of linagliptin free base and the following inactive ingredients: mannitol, pregelatinized starch, corn starch, copovidone, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, polyethylene glycol, and red ferric oxide.

CLINICAL PHARMACOLOGY: top of page

CLINICAL PHARMACOLOGY
Mechanism of Action
Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretin hormones are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta-cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha-cells, resulting in a reduction in hepatic glucose output.

INDICATIONS AND USAGE  top of page

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

Important limitations of use:
-Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
-Has not been studied in combination with insulin .

CONTRAINDICATIONS top of page

History of hypersensitivity reaction to linagliptin, such as urticaria, angioedema, or bronchial hyperreactivity

PRECAUTIONS top of page

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.

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with TRADJENTA or any other antidiabetic drug.

DRUG INTERACTIONS
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.


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.

Nursing mothers: Caution should be exercised when TRADJENTA is administered to a nursing woman.

Pediatric patients: Safety and effectiveness of TRADJENTA in patients below the age of 18 have not been established.

Renal or hepatic impairment: No dose adjustment recommended

ADVERSE REACTIONS top of page

Adverse reactions reported in geq5% 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) .


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

DOSAGE AND ADMINISTRATION  top of page

Recommended Dosing
The recommended dose of TRADJENTA is 5 mg once daily.

TRADJENTA tablets can be taken with or without food.


Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea)
When TRADJENTA is used in combination with an insulin secretagogue (e.g., sulfonylurea), a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia [see Warnings and Precautions].

HOW SUPPLIED top of page

TRADJENTA tablets are available as light red, round, biconvex, bevel-edged, film-coated tablets containing 5 mg of linagliptin. TRADJENTA tablets are debossed with “D5” on one side and the Boehringer Ingelheim logo on the other side.

They are supplied as follows:
Bottles of 30 (NDC 0597-0140-30)
Bottles of 90 (NDC 0597-0140-90)
Bottles of 1000 (NDC 0597-0140-10)
Cartons containing 10 blister cards of 10 tablets each (10 x 10) (NDC 0597-0140-61)
If repackaging is required, dispense in a tight container as defined in USP.


Storage
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Store in a safe place out of reach of children

REFERENCE

Package Insert data: 
Distributed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA

Marketed by:
Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, CT 06877 USA
and
Eli Lilly and Company
Indianapolis, IN 46285 USA

Licensed from:
Boehringer Ingelheim International GmbH, Ingelheim, Germany

Copyright 2011 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED
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