OZEMPIC 0.68 MG

What is OZEMPIC?

OZEMPIC 0.68 MG contains SEMAGLUTIDE : 0.68 MG. It is listed in the Health Canada Drug Product Database under DIN 02540258, held by NOVO NORDISK CANADA INC, supplied as SOLUTION for SUBCUTANEOUS administration. Health Canada currently lists it as marketed, status dated 22-Dec-2023. 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 OZEMPIC used for?

OZEMPIC® is indicated for the once-weekly treatment of adult patients with type 2 diabetes 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. • metformin or a sulfonylurea and a sodium-glucose cotransporter 2 inhibitor (SGLT2i), when diet and exercise plus metformin or a sulfonylurea, in addition to an SGLT2i, do not achieve adequate glycemic control. • basal insulin with metformin, when diet and exercise plus basal insulin with metformin do not achieve adequate glycemic control (see 14 Clinical Trials). OZEMPIC® is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.

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?

OZEMPIC® is to be administered once weekly, at any time of the day, with or without meals. OZEMPIC® should not be administered daily. The day of weekly administration can be changed if necessary as long as the time between two doses is at least 2 days (>48 hours). OZEMPIC® can be used as monotherapy when metformin is not tolerated or is contraindicated, or as combination therapy with one or more antidiabetic drugs (metformin, sulfonylurea [SU], basal insulin, SGLT2i). OZEMPIC® should not be given in combination with other GLP-1 analogs. Combination with DPP-4 inhibitors has not been studied. When OZEMPIC® is added to existing metformin therapy, the current dose of metformin can be continued unchanged. An increased risk of hypoglycemia was seen with concomitant use of SU or basal insulin with OZEMPIC®. When OZEMPIC® is added to existing therapy of a sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycemia. In clinical trials, insulin dose was decreased by 20% at onset of OZEMPIC® treatment. See 7 Warnings and Precautions. Recommended Dose and Dosage Adjustment The recommended starting dose of OZEMPIC® is 0.25 mg once weekly. OZEMPIC® 0.25 mg is not a therapeutic dose. After 4 weeks, the dose should be increased to 0.5 mg once weekly. If additional glycemic control is needed after 4 weeks, the dose may be increased to 1 mg once weekly to further improve glycemic control. If additional glycemic control is needed after 4 weeks, the dose may be increased to 2 mg once weekly. The maximum recommended dose is 2 mg once weekly. OZEMPIC® is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed without dose adjustment. Inspect OZEMPIC® visually before use. It should appear clear and colourless. Do not use OZEMPIC® if particulate matter and colouration is seen. When using OZEMPIC® with insulin, instruct patients to administer as separate injections and to never mix the products. It is acceptable to inject OZEMPIC® and insulin in the same body region but the injections should not be adjacent to each other. Rotate injection sites with each dose. Do not use the same site for each injection. OZEMPIC® should not be administered intravenously or intramuscularly. Missed Dose If a dose is missed, it should be administered as soon as possible within 5 days after the missed dose. If more than 5 days have passed, 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.

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

How is it stored and handled?

Before opening: Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from the cooling element. During use: You can keep the pen for 8 weeks when stored at a temperature below 30°C or in a refrigerator (2°C – 8°C). Do not freeze. When you are not using the pen, keep the pen cap on in order to protect it from light. Do not use this medicine if the solution is not clear and colourless. Do not leave the pen in a car or another place where it can get too hot or too cold. Do not inject OZEMPIC® which has been frozen. Do not inject OZEMPIC® which has been exposed to direct sunlight. Do not expose your pen to dust, dirt or liquid. Do not wash, soak or lubricate your pen. Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the flow before you inject.

How is it supplied?

OZEMPIC® is provided in a pre-filled, multi-dose, disposable pen, which contains the drug solution, semaglutide in a 1.5 mL or 3 mL cartridge. There are six variants of the pre-filled multi-dose pen for OZEMPIC®: - OZEMPIC® 0.25 mg, 0.5 mg/dose contains 1.5 mL solution, equivalent to 2 mg semaglutide (4 or 6 doses). - OZEMPIC® 0.25 mg, 0.5mg/dose contains 3 mL solution, equivalent to 2 mg semaglutide (4 or 6 doses). - OZEMPIC® 0.25 mg, 0.5mg/dose contains 3 mL, equivalent to 4 mg semaglutide (8 doses). - OZEMPIC® 1 mg/dose, contains 3 mL solution, equivalent to 4 mg semaglutide (4 doses). - OZEMPIC® 1 mg/dose contains 3 mL, equivalent to 8 mg semaglutide (8 doses). - OZEMPIC® 2 mg/dose, contains 3 mL solution, equivalent to 8 mg semaglutide (4 doses). Disposable needles are included in the OZEMPIC® package. Pack sizes of: Carton of 1 Pen • Pen delivers doses of 0.25 mg or 0.5 mg • 6 or 8 disposable needles • Intended to be used for dose escalation and maintenance treatment at the 0.5 mg dose Carton of 1 Pen • Pen delivers 1 mg doses • 4 or 8 disposable needles • Intended to be used for maintenance treatment at the 1 mg dose only Carton of 1 Pen • Pen delivers 2 mg doses • 4 disposable needles • Intended to be used for the maintenance treatment at the 2 mg dose only.

Contraindications

OZEMPIC® 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). OZEMPIC® is contraindicated in patients with hypersensitivity to OZEMPIC® or to any of the product components. OZEMPIC® should not be used during pregnancy or breastfeeding. OZEMPIC® 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.

Warnings and precautions

Risk of Thyroid C-cell Tumours: Semaglutide causes treatment-dependent thyroid C-cell tumours at clinically relevant exposures in both sexes of rats and mice. It is unknown whether semaglutide causes thyroid C-cell tumours, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. OZEMPIC® 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 tumours. Patients should be counseled regarding the risk and symptoms of thyroid tumours (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Cardiovascular: OZEMPIC® causes an increase in heart rate and a prolongation of the PR interval of the electrocardiogram. Caution should be observed in patients who have cardiac conditions that might be worsened by an increase in heart rate, such as tachyarrhythmias, or with pre-existing conduction system abnormalities. Hypoglycemia: Increased risk of hypoglycemia with concomitant use of sulfonylurea or basal insulin. Dose reduction of sulfonylurea or insulin should be considered. Gastrointestinal: Use of GLP-1 receptor agonists may be associated with severe gastrointestinal disease (ileus). Events of delayed gastric emptying, dysgeusia, intestinal obstruction, and ileus have been reported. Pancreatitis: Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. If pancreatitis is suspected, OZEMPIC® should be discontinued. Acute Gall Bladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported. If suspected, gallbladder studies and appropriate clinical follow-up are indicated. Hypersensitivity: Severe, life-threatening, generalized allergy, including anaphylaxis, may occur. If a hypersensitivity reaction occurs, discontinue OZEMPIC® and promptly seek medical advice. Diabetic Retinopathy Complications: More events of diabetic retinopathy complications occurred in patients treated with OZEMPIC® in a 2-year trial. Rapid improvement in glucose control may lead to temporary worsening of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored. Renal Insufficiency: Use with caution in patients with impaired renal function as gastrointestinal adverse reactions may cause dehydration and deterioration of renal function. Monitor renal function.

What can be used instead?

Other Canadian products sharing ATC code A10BJ06 SEMAGLUTIDE. 9 of 17 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 SEMAGLUTIDE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. SEMAGLUTIDE appears in 152 registered pack listings across 13 markets, published on 10 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.