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TRULICITY is a brand name for Dulaglutide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TRULICITY (dulaglutide) is indicated for the once-weekly treatment of adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with: • diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance. • metformin, when diet and exercise plus…
Verbatim from this product's HC label. Tap a section to expand.
3 Pharmacokinetics). 2 CONTRAINDICATIONS • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, (see
, and 16 NON-CLINICAL TOXICOLOGY). 1 Dosing Considerations • When initiating Trulicity, consider reducing the dose of concomitantly administered insulins and insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycemia (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
75 mg once weekly, administered subcutaneously. 5 mg once weekly for additional glycemic control. 5 mg dose. 5 mg once weekly after at least 4 weeks on the 3 mg dose. 3 Pharmacokinetics). Monitor renal function in patients with renal impairment reporting severe gastrointestinal reactions which may worsen the renal function.
• Hepatic Insufficiency: There is a limited experience in patients with mild, moderate, or severe hepatic impairment. 3 Pharmacokinetics). No dose adjustment is required in patients with hepatic insufficiency. 3 Pharmacokinetics). 3 Pediatrics).
4 Administration Trulicity can be administered any time of day, with or without meals, and should be injected subcutaneously in the abdomen, thigh, or upper arm. Patients may have help from another person for injection in the upper arm.
Trulicity®, dulaglutide Product Monograph Page 6 of 80 Trulicity should be administered subcutaneously with no dilution. Trulicity solution should be inspected prior to each injection, and the solution should be used only if it is clear, colourless, and contains no particles.
Trulicity and insulin should not be mixed in the same syringe, and must be administered as two separate injections in two different injection sites. 5 Missed Dose If a dose is missed, it should be administered as soon as possible if there are at least 3 days (72 hours) until the next scheduled dose.
If less than 3 days remain before the next scheduled dose, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
). 2 Breast-feeding). Trulicity®, dulaglutide Product Monograph Page 5 of 80 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • In male and female rats, dulaglutide causes dose-dependent and treatment-duration- dependent thyroid C-cell tumors (adenomas and carcinoma) after lifetime exposure (see 16 NON-CLINICAL TOXICOLOGY).
It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. • 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).
It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS,
• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). • In patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) (see 7 WARNINGS AND PRECAUTIONS).
2 Breast-feeding). Trulicity®, dulaglutide Product Monograph Page 5 of 80
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Changing Weekly Dosing Schedule The day of weekly administration can be changed, if necessary, as long as the last dose was administered 3 days (72 hours) or more before. 5 OVERDOSAGE Overdoses have been reported in clinical studies.
, nausea, vomiting) and non-severe hypoglycemia. In the event of overdose, appropriate supportive care (including frequent plasma glucose monitoring) should be initiated according to the patient’s clinical signs and symptoms. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Trulicity is packaged in a cardboard outer carton and is available in packs of 2 or 4 single-use, prefilled pens. Not all pack sizes and presentations may be marketed.
5 mL of solution. 5 mL of solution. 5 mL of solution. 5 mL citric acid anhydrous, mannitol, polysorbate 80, and trisodium citrate dihydrate in water for injection. 5 mL of solution. 7 WARNINGS AND PRECAUTIONS General Trulicity should not be used in patients with type 1 diabetes mellitus or for the treatment of patients with diabetic ketoacidosis.
Trulicity should not be administered intramuscularly. 5 mg per week based on area under the time-concentration curve (AUC) compared to controls (see 16 NON-CLINICAL TOXICOLOGY). A statistically significant increase in C-cell adenomas was observed in rats of both genders receiving dulaglutide at ≥3 times the human exposure.
Numerical increases in C-cell carcinomas occurred at 24 times the MRHD based on AUC and were considered to be treatment related despite the absence of statistical significance. Dulaglutide did not produce increased incidences of thyroid C-cell tumors in a rasH2 transgenic mouse model of carcinogenicity.
It is unknown whether Trulicity will cause thyroid C-cell tumors, including medullary thyroid cancer (MTC), in humans, as the human relevance of dulaglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies.
One (1) case of MTC was reported in a patient treated with Trulicity. The patient with MTC had a markedly elevated calcitonin value at baseline, 8 times […]