Tradjenta® (linagliptin) Tablets: Glycemic Control for Adult Patients With Type 2 Diabetes Mellitus
A supplement to Clinical Endocrinology News.
This newsletter was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc and Lilly USA, LLC.
TOPICS
Overview of Type 2 Diabetes Mellitus
Epidemiology
Pathophysiology and Pathogenesis
Treatment Guidelines and Algorithms
Tradjenta® (linagliptin) Tablets
Mechanism of Action
Pharmacokinetics
Clinical Efficacy and Safety Data
Conclusion
INDICATIONS 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.
Please click here for the Tradjenta full Prescribing Information, including Patient Information.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
TRADJENTA is contraindicated in patients with a history of hypersensitivity reaction to linagliptin, such as urticaria, angioedema or bronchial hyperreactivity.
WARNINGS AND PRECAUTIONS
Use with Medications Known to Cause Hypoglycemia
Insulin secretagogues and insulin are known to cause hypoglycemia. The use of TRADJENTA in combination with an insulin secretagogue (e.g., sulfonylurea) was associated with a higher rate of hypoglycemia compared with placebo in a clinical trial. Therefore, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia when used in combination with TRADJENTA.
Macrovascular Outcomes
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with TRADJENTA or any other antidiabetic drug.
ADVERSE REACTIONS
Adverse reactions reported in ≥5% 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. When TRADJENTA was administered in combination with metformin and a sulfonylurea, 181 of 792 (22.9%) patients reported hypoglycemia compared with 39 of 263 (14.8%) patients administered placebo in combination with metformin and a sulfonylurea. In patients receiving TRADJENTA as add-on therapy to a stable dose of insulin severe hypoglycemic events were reported in 11 (1.7%) patients compared with 7 (1.1%) for placebo.
In the clinical trial program, pancreatitis was reported in 15.2 cases per 10,000 patient-years of exposure while being treated with TRADJENTA compared with 3.7 cases per 10,000 patient-years of exposure while being treated with comparator (placebo and active comparator, sulfonylurea). Three additional cases of pancreatitis were reported following the last administered dose of linagliptin.
DRUG INTERACTIONS
The efficacy of TRADJENTA may be reduced when administered in combination with a strong P-glycoprotein or CYP3A4 inducer (e.g., rifampin). Therefore, use of alternative treatments to TRADJENTA is strongly recommended.
USE IN SPECIFIC POPULATIONS
There are no adequate and well-controlled studies in pregnant women. Therefore, TRADJENTA should be used during pregnancy only if clearly needed.
It is not known whether linagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRADJENTA is administered to a nursing woman.
The safety and effectiveness of TRADJENTA in patients below the age of 18 have not been established. |
