TRULICITY™ is a glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

• Not recommended as first-line therapy for patients inadequately controlled on diet and exercise (1, 5.1).
• Has not been studied in patients with a history of pancreatitis. Consider another antidiabetic therapy (1, 5.2).
• Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
• Not for patients with pre-existing severe gastrointestinal disease.
• Has not been studied in combination with basal insulin.

• Administer once weekly at any time of day (2.1).
• Inject subcutaneously in the abdomen, thigh, or upper arm (2.1).
• Initiate at 0.75 mg subcutaneously once weekly. Dose can be increased to 1.5 mg once weekly for additional glycemic control (2.1).
• If a dose is missed administer within 3 days of missed dose (2.1).

• Injection: 0.75 mg/0.5 mL solution in a single-dose pen (3)
• Injection: 1.5 mg/0.5 mL solution in a single-dose pen (3)
• Injection: 0.75 mg/0.5 mL solution in a single-dose prefilled syringe (3)
• Injection: 1.5 mg/0.5 mL solution in a single-dose prefilled syringe (3)

• Do not use in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4.1, 5.1, 13.1).
• Do not use if history of serious hypersensitivity to TRULICITY or any product components (4.2, 5.4).

• Thyroid C-cell tumors in animals: Counsel patients regarding the risk of medullary thyroid carcinoma and the symptoms of thyroid tumors (5.1).
• 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 history of pancreatitis (5.2).
• 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 (5.3).
• Hypersensitivity Reactions: Discontinue TRULICITY if suspected. Monitor and treat promptly per standard of care until signs and symptoms resolve (5.4).
• Renal Impairment: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions (5.5).
• Macrovascular outcomes: There have been no studies establishing conclusive evidence of macrovascular risk reduction with TRULICITY or any other antidiabetic drug (5.7).

The most common adverse reactions, reported in ≥5% of patients treated with TRULICITY are: nausea, diarrhea, vomiting, abdominal pain, and decreased appetite (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications (7.1, 12.3).

• Pregnancy: TRULICITY may cause fetal harm; only use if potential benefit justifies potential risk to fetus (8.1).
• Nursing Mothers: Discontinue nursing or discontinue TRULICITY (8.3).
• Renal Impairment: No dosage adjustment recommended. Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions (5.5, 8.7).