Dulaglutide SC Injection is a glucagon-like peptide-1 (GLP-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.

Dulaglutide 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.

The recommended initiating dose of Dulaglutide is 0.75 mg once weekly. The dose may be increased to 1.5 mg once weekly for additional glycemic control. The maximum recommended dose is 1.5 mg once weekly. Administer Dulaglutide once weekly, any time of day, with or without food. Dulaglutide should be injected subcutaneously in the abdomen, thigh, or upper arm.

If a dose is missed, instruct patients to administer as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose. If less than 3 days remain before the next scheduled dose, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule. The day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before.

Dulaglutide 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 Dulaglutide. Drug levels of oral medications with a narrow therapeutic index should be adequately monitored when concomitantly administered with Dulaglutide. In clinical pharmacology studies, Dulaglutide did not affect the absorption of the tested, orally administered medications to a clinically relevant degree.

Dulaglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2. Dulaglutide is contraindicated in patients with a prior serious hypersensitivity reaction to Dulaglutide or any of the product components.

The most common adverse reactions, reported in ≥5% of patients treated with Dulaglutide are: nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.

Dulaglutide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The presence of dulaglutide in milk of treated lactating animals was not determined. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Dulaglutide and any potential adverse effects on the breastfed infant from Dulaglutide or from the underlying maternal condition.

Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

Hypoglycemia: When Dulaglutide is used with an insulin secretagogue (e.g., a sulfonylurea) or insulin, consider lowering the dose of the sulfonylurea or insulin to reduce the risk of hypoglycemia.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) have occurred. Discontinue Dulaglutide and promptly seek medical advice.

Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.

Severe Gastrointestinal Disease: Use may be associated with gastrointestinal adverse reactions, sometimes severe. Has not been studied in patients with severe gastrointestinal disease and is not recommended in these patients.

Diabetic Retinopathy Complications: Have been reported in a cardiovascular outcomes trial. Monitor patients with a history of diabetic retinopathy.

Pediatric Use: Safety and effectiveness of Dulaglutide have not been established in pediatric patients. Dulaglutide is not recommended for use in pediatric patients younger than 18 years.

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

Renal Impairment: No dosage adjustment recommended. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions.

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.

GLP-1 receptor agonists

Store Dulaglutide in the refrigerator at 2°C to 8°C. Do not use Dulaglutide beyond the expiration date. If needed, each single-dose pen can be kept at room temperature, not to exceed 30°C for a total of 14 days. Do not freeze Dulaglutide.