Indications

Trulicity 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 melltus who have established cardiovascular disease or multiple cardiovascular risk factors.

Pharmacology

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 intracollular cyclic AMP (cAMP) in beta cells leading to glucose-dependent insulin release. Dulaglutide also
decmases glucagon secretion and slows gastric emptying.

Dosage & Administration

The recommended initiating dose of Dulaglutide is 0.75 mg once weekly. The dose may be increased to 15 mg once weekly for additional glycemie control. The maximum recommended dose is 1.5 mg once
weokly. Administer Dulaglutide once woekly, any time of day, with or without food. Dulaglutide should be injected subcutancously in the abdomen, thigh, or upper arm.

If a dose is missed, instruct patients to administer as soon as possible if there are at loast 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 thoir regular once weekly dosing schedule. The day of woekly administration can be changed itf
necessary as long as the last dose was administered 3 or more days before.

nteraction

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

Contraindications

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.

Side Effects

The most common adverse reactions, reported in 25% of patients treated with Trulicity are: nausea, diarrhea, vomiting, abdominal pain, and decreased appetite

Pregnancy & Lactation

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

Precautions & Warnings

Pancreatitis: Has boen reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confired. Consider other antidiabetie therapies in patients with history of
pancreatitis.
Hypoglycemia: When Trulicity 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 roactions (e.g., anaphylactic roactions and angioedema) have occurred. Discontinue Trulicity and promptly soek 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.

Use in Special Populations

Pediatric Use: Safety and effectiveness of Trulicity have not been established in pediatric patients. Trulicity 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, Trulicity should be used with caution in these patient pop