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|Plan Name||Plan Type|
Tradjenta Drug Status
*Source: Fingertip Formulary, health plan or state listed above, and/or data on file, Boehringer Ingelheim Pharmaceuticals, Inc. as of June 2017. Percentage of covered lives represent a weighted average of both commercial and Part D availability. "Patients" consists of Commercially and Medicare Part D insured lives.
Placement on formulary does not establish clinical comparability of products, including safety and efficacy, and is not a guarantee of full or partial coverage and/or payment. Contact health plan, state, or www.medicare.gov for most current information, as it may change without notice. This is not intended to be an exhaustive list of all plans in your area. Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly USA, LLC do not sponsor or endorse any particular plan, and the company/plan names listed do not imply their endorsement of Boehringer Ingelheim Pharmaceuticals, Inc., Lilly USA, LLC, or the product(s) referenced. Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the trademark Tradjenta® under license. Other referenced trademarks are owned by third parties.
INDICATION AND IMPORTANT LIMITATIONS OF USE
TRADJENTA 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 patients with a history of pancreatitis, and it is unknown if using TRADJENTA increases the risk of developing pancreatitis in these patients.
IMPORTANT SAFETY INFORMATION
TRADJENTA is contraindicated in patients with a history of hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity.
WARNINGS AND PRECAUTIONS
Acute pancreatitis, including fatal pancreatitis, has been reported in patients taking TRADJENTA. Take careful notice of potential signs and symptoms of pancreatitis and, if suspected, promptly discontinue and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using TRADJENTA.
Heart failure has been observed with two other members of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. Consider the risks and benefits of TRADJENTA in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment. Monitor patients for signs and symptoms. Advise patients of the symptoms of heart failure and to immediately report such symptoms. If heart failure develops consider discontinuation of TRADJENTA.
Use with Medications Known to Cause Hypoglycemia
The use in combination with insulin or insulin secretagogues (e.g., sulfonylurea) increases the risk of hypoglycemia. A lower dose of insulin or insulin secretagogue may be required.
Serious hypersensitivity reactions have been reported in patients treated with TRADJENTA including anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment, with some occurring after the first dose. If a serious hypersensitivity reaction is suspected, discontinue, assess for other potential causes for the event, and institute alternative treatment for diabetes.
Angioedema has also been reported with other DPP-4 inhibitors. Use caution in a patient with a history of angioedema to another DPP-4 inhibitor because it is unknown whether such patients will be predisposed to angioedema with TRADJENTA.
Severe and Disabling Arthralgia
Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider linagliptin as a possible cause for severe joint pain and/or disabling arthralgia and discontinue, if appropriate.
There have been 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.
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with TRADJENTA.
MOST COMMON ADVERSE REACTIONS (≥5%)
Nasopharyngitis, hypoglycemia (when used in combination with sulfonylurea)
The efficacy of TRADJENTA may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Alternative treatments should be used.
USE IN SPECIFIC POPULATIONS
Use during pregnancy only if clearly needed. Exercise caution when administering to a nursing woman.