Dulaglutide

What it is and how it works

Mechanism of Action TRULICITY contains dulaglutide, which is a human GLP-1 receptor agonist with 90% amino acid sequence homology to endogenous human GLP-1 (7-37). Dulaglutide activates the GLP-1 receptor, a membrane-bound cell-surface receptor coupled to adenylyl cyclase in pancreatic beta cells. Dulaglutide increases intracellular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also decreases glucagon secretion and slows gastric emptying.

Mechanism class: Glucagon-like Peptide-1 (GLP-1) Agonists

Indications

® is indicated: 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. TRULICITY ® is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated : 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 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 , 5.2 ). Not for treatment of type 1 diabetes mellitus .

Dosage and administration (summary)

Adult Dosage Recommended starting dosage is 0.75 mg injected subcutaneously once weekly. Increase dosage to 1.5 mg once weekly for additional glycemic control. If additional glycemic control is needed, increase dosage in 1.5 mg increments after at least 4 weeks on the current dosage. Maximum recommended dosage is 4.5 mg injected subcutaneously once weekly. Pediatric Dosage Recommended starting dosage is 0.75 mg injected subcutaneously once weekly. If additional glycemic control is needed, increase dosage to the maximum recommended dosage of 1.5 mg once weekly after at least 4 weeks on the 0.75 mg dosage.

Contraindications

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 .

Warnings and precautions

Thyroid C-cell Tumors: See Boxed Warning . Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed . Hypoglycemia: Concomitant use with an insulin secretagogue or insulin may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin secretagogue or insulin may be necessary . Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) have occurred. Discontinue TRULICITY and promptly seek medical advice .

Pregnancy

Pregnancy Risk Summary Limited data with TRULICITY in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy .

Storage and supply

Product: 50090-6571 NDC: 50090-6571-0 .5 mL in a SYRINGE / 4 in a CARTON

Source: Dulaglutide (Trulicity) — US FDA prescribing information, 2023-08-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.