RYBELSUS 3 MG

What is RYBELSUS?

RYBELSUS 3 MG contains SEMAGLUTIDE : 3 MG. It is listed in the Health Canada Drug Product Database under DIN 02497581, held by NOVO NORDISK CANADA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 19-Apr-2020. 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 RYBELSUS used for?

RYBELSUS® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus: • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; • in combination with other medicinal products for the treatment of diabetes (see 14 CLINICAL TRIALS for patient populations and drug combinations tested). • to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who have established cardiovascular disease or are at high risk for these events.

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?

Do not take more than one tablet of Rybelsus® daily. Do not take two or more tablets of Rybelsus® to obtain a higher dose. Initial Formulation of Rybelsus® 3 mg, 7 mg, 14 mg tablets: The starting dose of Rybelsus® is 3 mg once daily. After 30 days, the dose should be increased to a maintenance dose of 7 mg once daily. If additional glycemic control is needed after at least 30 days on the 7 mg dose, the dose can be increased to a maintenance dose of 14 mg once daily. This regimen is intended to mitigate gastrointestinal symptoms during dose escalation. The maximum recommended single daily dose of oral semaglutide is 14 mg. Optimized Formulation of Rybelsus® 1.5 mg, 4 mg, 9 mg tablets: The starting dose of Rybelsus® is 1.5 mg once daily. After 30 days, the dose should be increased to a maintenance dose of 4 mg once daily. If additional glycemic control is needed after at least 30 days on the 4 mg dose, the dose can be increased to a maintenance dose of 9 mg once daily. This regimen is intended to mitigate gastrointestinal symptoms during dose escalation. The maximum recommended single daily dose of oral semaglutide is 9 mg. Rybelsus® must be taken on an empty stomach at least 30 minutes before the first food, beverage or other oral medications of the day. Waiting less than 30 minutes is likely to decrease the amount of semaglutide absorbed. Rybelsus® should be taken with no more than half a glass of water equivalent to 120 mL. A larger volume of water is likely to decrease the amount of semaglutide absorbed. Rybelsus® should be swallowed whole. Do not split, crush or chew. Missed Dose: If a dose is missed, the missed dose should be skipped, and the next dose should be taken the following day.

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

How is it stored and handled?

Store at room temperature (15°C to 30°C) out of the reach of children. Rybelsus® must be stored in the original blister packaging to protect from moisture and light. Take the tablet directly after removing from blister card. Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Removing it too soon can prevent it from working as planned. Do not use this medicine if you notice that the package is damaged or shows signs of tampering.

How is it supplied?

Initial Formulation of Rybelsus® 3 mg, 7 mg and 14 mg tablets: 3 mg tablets: white to light yellow, oval shaped, debossed with “3” on one side and “novo” on the other side. Supplied in green coloured cartons containing alu/alu blisters in pack sizes of 30, 60 or 90 tablets. 7 mg tablets: white to light yellow, oval shaped, debossed with “7” on one side and “novo” on the other side. Supplied in red coloured cartons containing alu/alu blisters in pack sizes of 30, 60 or 90 tablets. 14 mg tablets: white to light yellow, oval shaped, debossed with “14” on one side and "novo" on the other side. Supplied in blue coloured cartons containing alu/alu blisters in pack sizes of 30, 60 or 90 tablets. Optimized Formulation of Rybelsus® 1.5 mg, 4 mg and 9 mg tablets: 1.5 mg tablets: white to light yellow, round shaped, debossed with “1.5” on one side and "novo" on the other side. Supplied in green coloured cartons containing alu/alu blisters in pack sizes of 30 tablets. 4 mg tablets: white to light yellow, round shaped, debossed with “4” on one side and "novo” on the other side. Supplied in red coloured cartons containing alu/alu blisters in pack sizes of 30 or 90 tablets. 9 mg tablets: white to light yellow, round shaped, debossed with “9” on one side and "novo" on the other side. Supplied in blue coloured cartons containing alu/alu blisters in pack sizes of 30 or 90 tablets.

Contraindications

Rybelsus® is contraindicated in patients who are hypersensitive to Rybelsus® or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. Rybelsus® is contraindicated in patients who have a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Rybelsus® should not be used during pregnancy or breastfeeding.

Warnings and precautions

Risk of Thyroid C-cell Tumours: Semaglutide causes treatment-dependent thyroid C-cell tumours in rats and mice. It is unknown whether semaglutide causes thyroid C-cell tumours, including medullary thyroid carcinoma (MTC), in humans. Rybelsus® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Patients should be counseled regarding the risk and symptoms of thyroid tumours. Rybelsus® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. There is no therapeutic experience in patients with congestive heart failure New York Heart Association (NYHA) class IV and semaglutide is therefore not recommended in these patients. Cases of pulmonary aspiration have been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or deep sedation. The increased risk of residual gastric content due to delayed gastric emptying should be considered prior to performing procedures with general anaesthesia or deep sedation. This medicinal product contains 23 mg sodium per tablet, equivalent to 1% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Cardiovascular: Semaglutide causes an increase in heart rate. Caution should be observed in patients who have cardiac conditions that might be worsened by an increase in heart rate, such as tachyarrhythmias. Semaglutide causes a prolongation of the PR interval of the electrocardiogram. Caution should be observed in patients with pre-existing conduction system abnormalities or a history of rhythm disturbances. Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin: Patients treated with semaglutide in combination with an insulin secretagogue (e.g., sulfonylureas) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by reducing the dose of the secretagogue or insulin when initiating treatment with Rybelsus®. Gastrointestinal: Use of GLP-1 receptor agonists may be associated with severe gastrointestinal disease (ileus). Mild-moderate gastrointestinal events occurred more frequently in patients receiving Rybelsus® than placebo, and included nausea, diarrhea, and vomiting. Gastrointestinal adverse events may be co-reported with dizziness. Pancreatic: Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, Rybelsus® should be discontinued and appropriate management initiated; if confirmed, Rybelsus® should not be restarted. Acute Gall Bladder Disease: Acute events of gallbladder disease such as cholelithiasis or cholecystitis have been reported. Patients should be informed of the characteristic symptoms of gallbladder disease. Evaluate patients with suspected gallbladder disorders promptly and instruct patients to contact their physician for appropriate clinical follow-up if gallbladder disease is suspected. Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, may occur. If a hypersensitivity reaction occurs, the patient should discontinue Rybelsus® and promptly seek medical advice. Do not use in patients with a previous hypersensitivity to Rybelsus®.

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.