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RYBELSUS is a brand name for Semaglutide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 2025.12 4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT 2025.12 7 WARNINGS AND PRECAUTIONS 2025.12 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................ 2 TABLE OF…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Do not take more than one tablet of Rybelsus® daily. Do not take two or more tablets of Rybelsus® to obtain a higher dose. 2 Recommended Dose and Dosage Adjustment Different Rybelsus® tablets are available: Initial Formulation of Rybelsus® tablets: 3 mg, 7 mg, 14 mg.
5 mg, 4 mg, 9 mg.
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. 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. 5 mg tablet of the optimized formulation of Rybelsus and 3 mg tablets of the initial formulation of Rybelsus are intended for treatment initiation (starting dose) and are not intended for glycemic control.
The maximum recommended single daily dose of oral semaglutide is either 9 mg tablet of the optimized formulation of Rybelsus or 14 mg tablets of the initial formulation of Rybelsus. Taking more than one tablet to achieve a higher dose is not recommended.
1 Pediatrics). No dose adjustment of Rybelsus® is recommended based on age, sex, race, ethnicity, upper gastrointestinal disease, or hepatic impairment. Patients with Renal Insufficiency No dose adjustment is required for patients with mild, moderate or severe renal impairment.
3 PHARMACOKINETICS). 4 Administration 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.
). , severe or persistent abdominal pain, fever, jaundice). Evaluate patients with suspected gallbladder Rybelsus® (semaglutide tablets) Product Monograph Page 10 of 47 disorders promptly and instruct patients to contact their physician for appropriate clinical follow- up if gallbladder disease is suspected.
If cholelithiasis or cholecystitis are suspected, gallbladder studies and appropriate clinical follow-up are indicated. Immune Hypersensitivity Serious hypersensitivity reactions, including anaphylaxis, may occur with any GLP-1 receptor agonist, including Rybelsus®.
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®. Caution should be exercised with a history of angioedema or anaphylaxis with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to anaphylaxis with Rybelsus®.
Monitoring and Laboratory Tests Regular self-monitoring of blood glucose is not needed in order to adjust the dose of Rybelsus®. However, when initiating treatment with Rybelsus® in combination with a sulfonylurea or insulin it may become necessary to reduce the dose of the sulfonylurea or insulin in order to reduce the risk of hypoglycemia.
However, patients should be informed that response to all diabetic therapies should be monitored by periodic measurement of HbA1C levels, with a goal of decreasing these levels towards the normal range. HbA1C is especially useful for evaluating long-term glycemic control.
8% with comparator). Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Long-term glycemic control decreases the risk of diabetic retinopathy. Patients with a history of diabetic retinopathy should be monitored for worsening and treated according to clinical guidelines.
12 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................ 2 TABLE OF CONTENTS..................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 4 1 INDICATIONS ...................................................................................................... 1 Pediatrics ...............................................................................................
2 Geriatrics ............................................................................................... 4 2 CONTRAINDICATIONS ....................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................
5 4 DOSAGE AND ADMINISTRATION ..................................................................... 1 Dosing Considerations ........................................................................... 2 Recommended Dose and Dosage Adjustment ......................................
4 Administration ........................................................................................ 5 Missed Dose .......................................................................................... 6 5 OVERDOSAGE ....................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 7 7 WARNINGS AND PRECAUTIONS ...................................................................... 1 Special Populations .............................................................................
1 Pregnant Women ................................................................................. 2 Breast-feeding ...................................................................................... 3 Pediatrics .............................................................................................
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. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
See 7 WARNINGS AND PRECAUTIONS, Immune, Hypersensitivity. 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).
See 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis, Risk of Thyroid C-Cell Tumours. Rybelsus® should not be used during pregnancy or breastfeeding. 2 Breastfeeding. Rybelsus® (semaglutide tablets) Product Monograph Page 5 of 47
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Semaglutide in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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.
5 Missed Dose If a dose is missed, the missed dose should be skipped, and the next dose should be taken the following day.
Non-arteritic anterior ischaemic optic neuropathy (NAION) Data from epidemiological studies may indicate an increased risk of non-arteritic anterior ischaemic optic neuropathy (NAION) with a very rare frequency during treatment with semaglutide.
There is no identified time interval for when NAION may develop following treatment start. Patients reporting a sudden loss of vision (including partial loss) should be urgently referred for ophthalmological examination and treatment with semaglutide should be discontinued if NAION is confirmed.
Renal Renal Insufficiency and dehydration Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. This should be considered when treating patients with impaired renal function as nausea, vomiting, and diarrhoea, may cause dehydration, which could cause a deterioration of renal function.
Monitor renal function in patients with renal insufficiency reporting severe adverse gastrointestinal reactions. Rybelsus® (semaglutide tablets) Product Monograph Page 11 of 47 In patients treated with GLP-1 receptor agonists, there have been post-marketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis.
Some of these events were reported in patients without known underlying renal disease. 73m2) and no overall differences in safety were observed.
Reproductive Health:
Female and Male Potential Fertility The effect of semaglutide on fertility in humans is unknown. In female rats, following administration of subcutaneous semaglutide, an increase in oestrous length and a small reduction in number of ovulations were observed at doses associated with maternal body weight loss.
1 Pregnant Women The extent of exposure in pregnancy during clinical trials was very limited and there are no adequate and well-controlled studies of Rybelsus® in pregnant women. Therefore, Rybelsus® should not be used during pregnancy.
Women of childbearing potential are recommended to use contraception when treated with semaglutide. If a patient wishes to become pregnant, or pregnancy occurs, Rybelsus® should be discontinued. Rybelsus® should be discontinued at least 2 months before a planned pregnancy due to the long half-life of semaglutide (see 10 CLINICAL PHARMACOLOGY).
Use of Rybelsus® during pregnancy may cause fetal harm based on animal studies. Animal studies with subcutaneous semaglutide have shown reproductive and developmental toxicity at exposures below human exposure levels. Adverse developmental effects included fetal malformations in rats, rabbits, and monkeys and pre- and post-natal losses in monkeys.
In addition, SNAC was shown to result in fetotoxicity in rats (increase in the number of dams with stillborn pups) at a maternal dose of 1000 mg/kg/day (see 16 NON-CLINICAL TOXICOLOGY). As semaglutide and SNAC have both been demonstrated to cause developmental toxicity in animals, there may be a potential risk for an additive adverse developmental effect from exposure to Rybelsus® during pregnancy.
2 Breast-feeding Do not use this medicine if you are breast-feeding. The medicine passes into breast milk, and it is not known how it affects your baby. No measurable concentrations of semaglutide were found in breastmilk of lactating women.
Salcaprozate sodium was present in breastmilk and some of its metabolites were excreted in breastmilk at low concentrations. As a risk to a breast-fed child cannot be excluded, Rybelsus® should not be used during breast-feeding. 3 Pediatrics Pediatrics (< 18 years): The safety and efficacy of Rybelsus® have […]
4 Geriatrics .............................................................................................. 12 8 ADVERSE REACTIONS .................................................................................... 1 Adverse Reaction Overview .................................................................
2 Clinical Trial Adverse Reactions .......................................................... 3 Less Common Clinical Trial Adverse Reactions .................................. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ......................................................................................
5 Post-Market Adverse Reactions........................................................... 16 9 DRUG INTERACTIONS ..................................................................................... 2 Drug Interactions Overview ..................................................................
3 Drug-Behavioural Interactions.............................................................. 4 Drug-Drug Interactions ......................................................................... 5 Drug-Food Interactions ........................................................................
6 Drug-Herb Interactions ......................................................................... 7 Drug-Laboratory Test Interactions ....................................................... 18 10 CLINICAL PHARMACOLOGY...........................................................................
1 Mechanism of Action ............................................................................ 2 Pharmacodynamics ............................................................................. 3 Pharmacokinetics.................................................................................
20 11 STORAGE, STABILITY AND DISPOSAL ......................................................... 21 12 SPECIAL HANDLING INSTRUCTIONS ............................................................ 21 PART II: SCIENTIFIC INFORMATION .........................................................................
21 13 PHARMACEUTICAL INFORMATION ............................................................... 21 14 CLINICAL TRIALS ............................................................................................. 1 Trial Design and Study Demographics.................................................
2 Study Results ....................................................................................... 25 15 MICROBIOLOGY ............................................................................................... 35 16 NON-CLINICAL TOXICOLOGY .........................................................................
35 PATIENT MEDICATION INFORMATION ..................................................................... 40 Rybelsus® (semaglutide tablets) Product Monograph Page 4 of 47 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS 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.
1 Pediatrics […]