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Trulicity

Generic Name: Dulaglutide Injection
Drug Category: GLP-1 Receptor Agonist
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
  • To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with TRULICITY.

Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy.

Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.

TRULICITY is not recommended as a first-line therapy for patients who have inadequate glycemic control on diet and exercise because of the uncertain relevance of rodent C-cell tumor findings to humans.

TRULICITY has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis.

After initiation of TRULICITY, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting. If pancreatitis is suspected, promptly discontinue TRULICITY.

TRULICITY should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. TRULICITY is not a substitute for insulin.

TRULICITY has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis. The use of TRULICITY is not recommended in patients with pre-existing severe gastrointestinal disease.

TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC with use of TRULICITY and inform them of symptoms of thyroid tumors (e.g., mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with TRULICITY.

In male and female rats, dulaglutide causes a dose-related and treatment-duration dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined.

The risk of hypoglycemia is increased when TRULICITY is used in combination with insulin secretagogues (e.g., sulfonylureas) or insulin.

Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with TRULICITY.

In patients treated with GLP-1 receptor agonists, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis.

There is limited clinical experience in patients with mild, moderate, or severe hepatic impairment. Therefore, TRULICITY should be used with caution in these patient populations.

Adverse reactions of sinus tachycardia were reported more frequently in patients exposed to TRULICITY. The adverse reaction of first degree AV block occurred more frequently in patients treated with TRULICITY than placebo.

TRULICITY-treated patients developed anti-drug antibodies (ADAs) to the active ingredient in TRULICITY (i.e., dulaglutide).

TRULICITY slows gastric emptying and thus has the potential to reduce the rate of absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with TRULICITY.

Limited data with TRULICITY in pregnant women are not sufficient to determine a drug associated risk for major birth defects and miscarriage. Animal studies: early embryonic deaths, fetal growth reductions, and fetal abnormalities.

There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production.

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Off-label Uses

• Use in patients under the age of 18. GoToSource

• Type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. GoToSource

• First-line therapy for patients who have inadequate glycemic control on diet and exercise. GoToSource

Adverse Events

Cerebral infarction (stroke), acute myocardial infarction (heart attack) and angina pectoris (chest pain). GoToSource

Nasopharyngitis (inflammation of the nose and pharynx) and hypersensitivity reaction. GoToSource

Anti-drug antibodies (immune response where therapeutic effects of the treatment are inactivated) and enterocolitis (inflammation of small intestine and colon). GoToSource

Hematemesis (vomiting of blood), increased blood bilirubin (an orange-yellow substance made during the normal breakdown of red blood cells), esophagitis (inflammation of the esophagus), gastritis (inflammation of lining of stomach) and increased eosinophil count (type of white blood cell) and creatinine levels (signifies impaired kidney function or kidney disease). GoToSource

Pancreatitis (inflammation of pancreas) and hypoglycemia (low blood sugar). GoToSource

Litigation

Lawsuits filed for pancreatic cancer, pancreatitis and thyroid c-cell tumors. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 28, 2024