s with illustrations. The instructions can also be found at www.trulicity.com.
When using TRULICITY with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject TRULICITY and insulin in the same body region but the injections should not be adjacent to each other.
When injecting in the same body region, advise patients to use a different injection site each week. TRULICITY must not be administered intravenously or intramuscularly.
TRULICITY solution should be visually inspected for particulate matter and discoloration prior to administration.
3 DOSAGE FORMS AND STRENGTHS
Injection: 0.75 mg/0.5 mL or solution in a single-dose pen
Injection: 1.5 mg/0.5 mL solution in a single-dose pen
Injection: 0.75 mg/0.5 mL solution in a single-dose prefilled syringe
Injection: 1.5 mg/0.5 mL solution in a single-dose prefilled syringe
4 CONTRAINDICATIONS
4.1 Medullary Thyroid Carcinoma
TRULICITY is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions (5.1)].
4.2 Hypersensitivity
TRULICITY is contraindicated in patients with a prior serious hypersensitivity reaction to dulaglutide or to any of the product components [see Warnings and Precautions (5.4)].
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Thyroid C-cell Tumors
In male and female rats, dulaglutide causes a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure [see Nonclinical Toxicology (13.1)].
Glucagon-like peptide (GLP-1) receptor agonists have induced thyroid C-cell adenomas and carcinomas in mice and rats at clinically relevant exposures. It is unknown whether TRULICITY will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of this signal could not be determined from the clinical or nonclinical studies.
One case of MTC was reported in a patient treated with TRULICITY. This patient had pretreatment calcitonin levels approximately 8 times the upper limit of normal (ULN).
TRULICITY is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the risk for MTC with the use of TRULICITY and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness).
The role of serum calcitonin monitoring or thyroid ultrasound monitoring for the purpose of early detection of MTC in patients treated with TRULICITY is unknown. Such monitoring may increase the risk of unnecessary procedures, due to the low specificity of serum calcitonin as a screening test for MTC and a high background incidence of thyroid disease. Very elevated serum calcitonin value may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further eva luation. Patients with thyroid nodules noted on physical examination or neck imaging should also be referred to an endocrinologist for further eva luation.
5.2 Pancreatitis
In Phase 2 and Phase 3 clinical studies, 12 (3.4 cases per 1000 patient years) pancreatitis related adverse reactions were reported in patients exposed to TRULICITY versus 3 in non-incretin compa |
