TRULICITY 1.5 MG / 0.5 ML

What is TRULICITY?

TRULICITY 1.5 MG / 0.5 ML contains DULAGLUTIDE : 1.5 MG / 0.5 ML. It is listed in the Health Canada Drug Product Database under DIN 02448602, held by ELI LILLY CANADA INC, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 24-Nov-2015. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is TRULICITY 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 maximal tolerated dose of metformin do not achieve adequate glycemic control. • metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control. • sodium glucose co-transporter 2 inhibitor (SGLT2i) with metformin, when diet and exercise plus SGLT2i with or without metformin do not achieve adequate glycemic control. • basal insulin with metformin, when diet and exercise plus basal insulin with or without metformin do not achieve adequate glycemic control. • prandial insulin with metformin, when diet and exercise plus basal or basal-bolus insulin therapy (up to two injections of basal or basal plus prandial insulin per day) with or without oral antihyperglycemic medications, do not achieve adequate glycemic control. TRULICITY is indicated as an adjunct to diet, exercise, and standard of care therapy to reduce the risk of non-fatal stroke in adults with type 2 diabetes mellitus who have multiple cardiovascular risk factors or established cardiovascular disease. TRULICITY is not a substitute for insulin. TRULICITY should not be used in patients with type 1 diabetes mellitus (formerly known as insulin-dependent diabetes mellitus or IDDM) or for the treatment of diabetic ketoacidosis.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

The recommended initiating dose of Trulicity is 0.75 mg once weekly, administered subcutaneously. The dose may be increased to 1.5 mg once weekly for additional glycemic control. If additional glycemic control is needed, the dose may be increased to 3 mg once weekly after at least 4 weeks on the 1.5 mg dose. If additional glycemic control is needed, the dose may be increased to a maximum of 4.5 mg once weekly after at least 4 weeks on the 3 mg dose. 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 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. 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. 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.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Trulicity should be stored in the refrigerator at 2° to 8°C, up to the expiration date. Do not use Trulicity beyond the expiration date. Do not freeze Trulicity. Do not use Trulicity if it has been frozen. Do not store in the freezer. Trulicity must be protected from light. Each single-use, prefilled pen may be stored unrefrigerated for up to 14 days at a temperature not to exceed 30°C.

How is it supplied?

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. Single-Use, Prefilled Pen – 0.75 mg / 0.5 mL Single-Use, Prefilled Pen – 1.5 mg / 0.5 mL Single-Use, Prefilled Pen – 3 mg / 0.5 mL Single-Use, Prefilled Pen – 4.5 mg / 0.5 mL

Contraindications

• Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. • In patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). • During Pregnancy or in breast-feeding women.

Warnings and precautions

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. 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. Cardiovascular: • Heart Rate Increase: Trulicity causes an increase in heart rate. Increases in heart rate may lead to worsening of cardiac conditions in patients with a history of ischemic heart disease or tachyarrhythmias. Caution should be observed in these patient populations. • PR Interval Prolongation: Trulicity causes a prolongation of the PR interval of the electrocardiogram. Prolongation of the PR interval has also been associated with an increased risk of incident atrial fibrillation; therefore, caution is warranted in patients with a history of atrial fibrillation. Caution should be observed in patients with underlying structural heart disease, pre-existing conduction system abnormalities, ischemic heart disease, or cardiomyopathies, as these patients may be at increased risk for developing cardiac conduction abnormalities. Endocrine and Metabolism: • Hypoglycemia: Patients receiving Trulicity in combination with an insulin secretagogue (for example, a sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of the insulin secretagogue or insulin. Gastrointestinal: • Severe Gastrointestinal Disease: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients. Events related to impaired gastric emptying, including severe gastroparesis, have been reported. Monitor and consider dose modification or discontinuation in patients who develop severe gastrointestinal symptoms while on treatment. Hepatic/Biliary/Pancreatic: • Pancreatitis: Pancreatitis has been reported with GLP-1 receptor agonists, including Trulicity. After initiation of Trulicity, observe patients carefully for signs and symptoms of pancreatitis, including persistent severe abdominal pain. If pancreatitis is suspected, Trulicity and other suspect medications should be discontinued promptly, confirmatory tests should be performed and appropriate management should be initiated. If pancreatitis is confirmed, Trulicity should not be restarted. Trulicity has not been studied in patients with a prior history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Immune: • Hypersensitivity Reactions: Systemic hypersensitivity adverse reactions, sometimes severe (e.g., severe urticaria, systemic rash, facial edema, lip swelling) occurred in 0.5% of patients on Trulicity in the four Phase 2 and five Phase 3 studies that assessed the 0.75 mg and 1.5 mg doses. There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Trulicity. If a hypersensitivity reaction occurs, discontinue use of Trulicity and other suspect medications and promptly seek medical advice. Trulicity should not be used following a hypersensitivity reaction. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patien

What can be used instead?

Other Canadian products sharing ATC code A10BJ05 DULAGLUTIDE. 2 of 6 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies DULAGLUTIDE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. DULAGLUTIDE appears in 26 registered pack listings across 11 markets, published on 9 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.