RYBELSUS 7 MG

What is RYBELSUS?

RYBELSUS 7 MG contains SEMAGLUTIDE : 7 MG. It is listed in the Health Canada Drug Product Database under DIN 02497603, 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 after the expiry date.

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 at clinically relevant exposures in both genders of 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. General: Rybelsus® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Not recommended in patients with congestive heart failure NYHA class IV. Pulmonary aspiration: Cases of pulmonary aspiration have been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or deep sedation due to delayed gastric emptying. Sodium Content: Contains 23 mg sodium per tablet, equivalent to 1% of the WHO recommended maximum daily intake. 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: Increased risk when used in combination with insulin secretagogues or insulin. Dose reduction of secretagogue or insulin may be needed. Gastrointestinal: May be associated with severe gastrointestinal disease (ileus). Mild-moderate GI events (nausea, diarrhea, vomiting) occurred more frequently than placebo. Pancreatic: Acute pancreatitis has been observed. Patients should be informed of symptoms. Discontinue if pancreatitis is suspected and do not restart if confirmed. Acute Gall Bladder Disease: Acute events such as cholelithiasis or cholecystitis have been reported. Patients should be informed of symptoms and evaluated if suspected. Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis, may occur. Discontinue and seek medical advice if a reaction occurs. 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.