Brand Name
Trulicity
Generic Name
Dulaglutide
View Brand Information FDA approval date: September 18, 2014
Classification: GLP-1 Receptor Agonist
Form: Injection
What is Trulicity (Dulaglutide)?
TRULICITY ® is 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 in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. TRULICITY ® is a glucagon-like peptide-1 receptor agonist 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 in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors. Limitations of Use: Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in these patients ( 1.
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Brand Information
TRULICITY (Dulaglutide)
WARNING: RISK OF THYROID C-CELL TUMORS
- 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[see Warnings and Precautions (.
- 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[see Contraindications (.
1INDICATIONS AND USAGE
TRULICITY
- As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older 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.
2DOSAGE FORMS AND STRENGTHS
Injection: TRULICITY is a clear and colorless solution available as:
- 0.75 mg/0.5 mL solution in a single-dose pen
- 1.5 mg/0.5 mL solution in a single-dose pen
- 3 mg/0.5 mL solution in a single-dose pen
- 4.5 mg/0.5 mL solution in a single-dose pen
3CONTRAINDICATIONS
TRULICITY is contraindicated in patients with:
- Personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Serious hypersensitivity reaction to dulaglutide or to any of the product components. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with TRULICITY
4ADVERSE REACTIONS
The following serious reactions are described below or elsewhere in the prescribing information:
- Risk of Thyroid C-cell Tumors
- Pancreatitis
- Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin
- Hypersensitivity Reactions
- Acute Kidney Injury
- Severe Gastrointestinal Disease
- Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy
- Acute Gallbladder Disease
4.1Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
4.2Postmarketing Experience
The following additional adverse reactions have been reported during post-approval use of TRULICITY. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Gastrointestinal: ileus
- Hepatobiliary: cholecystitis, cholelithiasis requiring cholecystectomy, cholestasis, elevation of liver enzymes, hepatitis
- Hypersensitivity: anaphylactic reactions, angioedema
- Renal: acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis
5OVERDOSAGE
Overdoses have been reported in clinical studies. Effects associated with these overdoses were primarily mild or moderate gastrointestinal events (e.g., nausea, vomiting) and non-severe hypoglycemia. In the event of overdose, appropriate supportive care (including frequent plasma glucose monitoring) should be initiated according to the patient's clinical signs and symptoms.
6DESCRIPTION
Dulaglutide is a human glucagon-like peptide-1 (GLP-1) receptor agonist. The molecule is a fusion protein that consists of 2 identical, disulfide-linked chains, each containing an N-terminal GLP-1 analog sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker and is produced using mammalian cell (Chinese hamster ovary) culture. The GLP-1 analog portion of dulaglutide is 90% homologous to native human GLP-1 (7-37). Structural modifications were introduced in the GLP-1 part of the molecule responsible for interaction with the enzyme dipeptidyl-peptidase-IV (DPP-4). Additional modifications were made in an area with a potential T-cell epitope and in the areas of the IgG4 Fc part of the molecule responsible for binding the high-affinity Fc receptors and half-antibody formation. The overall molecular weight of dulaglutide is approximately 63 kilodaltons.
TRULICITY (dulaglutide) injection is a clear, colorless, sterile, preservative-free solution for subcutaneous use. Each single-dose pen contains a 0.5 mL solution of 0.75 mg, 1.5 mg, 3 mg, or 4.5 mg of dulaglutide and the following excipients: citric acid anhydrous (0.07 mg), mannitol (23.2 mg), polysorbate 80 (0.10 mg for 0.75 mg and 1.5 mg; 0.125 mg for 3 mg and 4.5 mg), and trisodium citrate dihydrate (1.37 mg), in water for injection.
7HOW SUPPLIED/STORAGE AND HANDLING
Product: 50090-6571
NDC: 50090-6571-0 .5 mL in a SYRINGE / 4 in a CARTON
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling
- Inform patients that TRULICITY causes benign and malignant thyroid C-cell tumors in rats and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their physician
- Inform patients that persistent severe abdominal pain, that may radiate to the back and which may (or may not) be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Instruct patients to discontinue TRULICITY promptly, and to contact their physician, if persistent severe abdominal pain occurs
- Inform patients that the risk of hypoglycemia may be increased when TRULICITY is used in combination with an insulin secretagogue (such as a sulfonylurea) or insulin. Educate patients on the signs and symptoms of hypoglycemia
- Advise patients of the potential risk of dehydration due to gastrointestinal adverse reactions and take precautions to avoid fluid depletion. Inform patients treated with TRULICITY of the potential risk for worsening renal function and explain the associated signs and symptoms of renal impairment, as well as the possibility of dialysis as a medical intervention if renal failure occurs
- Inform patients that serious hypersensitivity reactions have been reported with use of TRULICITY. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking TRULICITY and seek medical advice promptly if such symptoms occur
- Inform patients to contact their physician if changes in vision are experienced during treatment with TRULICITY
- Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up
- Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant
- Inform patients if a dose is missed and there are at least 3 days (72 hours) until the next scheduled dose, they should administer it as soon as possible and then resume their usual once weekly dosing schedule. If a dose is missed and the next regularly scheduled dose is due in 1 or 2 days, inform the patient to not administer the missed dose and instead resume TRULICITY with the next regularly scheduled dose
- Advise patients treated with TRULICITY of the potential risk of gastrointestinal side effects
Eli Lilly and Company, Indianapolis, IN 46285, USA
US License Number 1891
Copyright © 2014, 2022, Eli Lilly and Company. All rights reserved.
TRU-0017-USPI-20221117
9DULAGLUTIDE
