Clinical Information
Gen. Code and Des.
81454 dulaglutide SUBCUT PEN INJCTR 4.5 MG/0.5
GCN and Des.
48573 dulaglutide SUBCUT PEN INJCTR 4.5 MG/0.5
Strength
4.5MG
Dose Form
PEN INJECTOR (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
68200600 INCRETIN MIMETICS
Active Ingredients
15693 dulaglutide 923950087
Inactive Ingredients
2272 mannitol 69658
2332 sodium citrate 68042
2551 polysorbates 9005645
These highlights do not include all the information needed to use TRULICITY safely and effectively. See full prescribing information for TRULICITY.
TRULICITY (dulaglutide) injection, for subcutaneous use
Initial U.S. Approval: 2014
WARNING: RISK OF THYROID C-CELL TUMORS
See full prescribing information for complete boxed warning.
Dulaglutide causes thyroid C-cell tumors in rats. It is unknown whether TRULICITY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors has not been determined (5.1, 13.1).
TRULICITY is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and symptoms of thyroid tumors (4, 5.1).
RECENT MAJOR CHANGES
Indications and Usage (1) 11/2022
Dosage and Administration (2.2) 11/2022
Warnings and Precautions (5.8) 6/2022
INDICATIONS AND USAGE
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).
DOSAGE AND ADMINISTRATION
Adult Dosage (2.1)
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 (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.
DOSAGE FORMS AND STRENGTHS
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)
CONTRAINDICATIONS
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).
WARNINGS AND PRECAUTIONS
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 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 (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).
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
Oral Medications: Delays gastric emptying and has the potential to reduce the rate of absorption of concomitantly administered oral medications (7.1, 12.3).
USE IN SPECIFIC POPULATIONS
Pregnancy: Should be used during pregnancy only if the potential benefit justifies the potential risk to fetus (8.1).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 12/2022
