umors, including medullary thyroid carcinoma (MTC), in humans as human relevance could not be determined from clinical or nonclinical studies (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) (4.1).
INDICATIONS AND USAGE
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.
DOSAGE AND ADMINISTRATION
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).
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: 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)
CONTRAINDICATIONS
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).
WARNINGS AND PRECAUTIONS
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).
ADVERSE REACTIONS
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.
DRUG INTERACTIONS
Dulaglutide slows gastric emptying and may impact absorption of concomitantly administered oral medications (7.1, 12.3).
USE IN SP |
