TRULICITY® is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated (1):

• 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 (1).
• Not recommended in patients with severe gastrointestinal disease, including severe gastroparesis (1, 5.6).

Adult Dosage (2.1)

• Recommended starting dosage is 0.75 mg injected subcutaneously once weekly.
• After 4 weeks, the dosage may be increased 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 (2.2)

• 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.

Recommendations Regarding Missed Dose (2.3)

• If a dose is missed, administer the missed dose as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose.

Important Administration Instructions (2.4)

• Administer once weekly at any time of day with or without food.
• Inject subcutaneously in the abdomen, thigh, or upper arm.

• 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: 3 mg/0.5 mL solution in a single-dose pen (3)
• Injection: 4.5 mg/0.5 mL solution in a single-dose pen (3)

• Patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (4, 5.1).
• Patients with a serious hypersensitivity reaction to dulaglutide or any of the product components (4, 5.4).

• Thyroid C-cell Tumors: See Boxed Warning (5.1).
• Pancreatitis: Has been reported in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed (5.2).
• 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 (5.3).
• Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) have occurred. Discontinue TRULICITY and promptly seek medical advice (5.4).
• Acute Kidney Injury: Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions (5.5).
• Severe Gastrointestinal Adverse Reactions: 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 (5.6).
• Diabetic Retinopathy Complications: Have been reported in a cardiovascular outcomes trial. Monitor patients with a history of diabetic retinopathy (5.7).
• Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated (5.8).
• Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures (5.9).

Most common adverse reactions (incidence ≥5%) 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.

Oral Medications: Delays gastric emptying and has the potential to reduce the rate of absorption of concomitantly administered oral medications (7.1, 12.3).

Pregnancy: Should be used during pregnancy only if the potential benefit justifies the potential risk to fetus (8.1).