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Tradjenta
Generic Name: Linagliptin
Drug Category: DPP-4 Inhibitor
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 2 years.
| Approved Uses |
|
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. There have been postmarketing reports of acute pancreatitis, including fatal pancreatitis, in patients taking TRADJENTA. There have been postmarketing reports of serious hypersensitivity reactions in patients treated with TRADJENTA. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment with TRADJENTA, with some reports occurring after the first dose. An association between DPP-4 inhibitor treatment and heart failure has been observed in cardiovascular outcomes trials for two other members of the DPP-4 inhibitor class. These trials evaluated patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease. Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP-4 inhibitor use. There have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors. Insulin secretagogues and insulin are known to cause hypoglycemia. The risk of hypoglycemia is increased when TRADJENTA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin Rifampin decreased linagliptin exposure, suggesting that the efficacy of TRADJENTA may be reduced when administered in combination with a strong P gp or CYP3A4 inducer. Therefore, use of alternative treatments is strongly recommended when linagliptin is to be administered with a strong P-gp or CYP3A4 inducer. The limited data with TRADJENTA use in pregnant women are not sufficient to inform of drug-associated risk for major birth defects and miscarriage. There is no information regarding the presence of linagliptin in human milk, the effects on the breastfed infant, or the effects on milk production. However, linagliptin is present in rat milk. |
| Off-label Uses |
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• Use in patients under the age of 18. GoToSource • Use in patients with type 1 diabetes. GoToSource |
| Adverse Events |
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Nasopharyngitis (inflammation of the nose and throat), anaphylaxis (life-threatening allergic reaction), angioedema (rapid swelling) and pancreatitis. GoToSource Increased risk of heart failure. GoToSource Liver toxicity. GoToSource Hypoglycemia (low blood sugar). GoToSource Increased rates of infection including urinary tract infections. GoToSource Increased risk of pancreatic cancer. GoToSource Severe joint pain. GoToSource Bullous pemphigoid (blistering skin condition). GoToSource |
| Litigation |
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Lawsuits filed for pancreatitis, pancreatic cancer and thyroid cancer. |
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