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Rybelsus is a brand name for Semaglutide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate • in combination with other medicinal products for the treatment of diabetes. For study…
Verbatim from this product's EMA label. Tap a section to expand.
5 mg once daily for one month. After one month, the dose should be increased to a maintenance dose of 4 mg once daily. If needed, the dose can be escalated to the next higher dose after a minimum of one month on the current dose. The recommended single daily maintenance doses are 4 mg, 9 mg, 25 mg and 50 mg.
The maximum recommended single daily dose of semaglutide is 50 mg. Rybelsus should always be used as one tablet per day. Taking more than one tablet a day should not be done to achieve the effect of a higher dose. Switching from subcutaneous to oral semaglutide The effect of switching between oral and subcutaneous semaglutide cannot easily be predicted because oral semaglutide displays higher pharmacokinetic variability in absorption compared to subcutaneous semaglutide.
5 mg once weekly can be transitioned to oral semaglutide 4 mg or 9 mg once daily. Patients treated with subcutaneous semaglutide 1 mg once weekly can be transitioned to oral semaglutide 9 mg or 25 mg once daily. Patients treated with subcutaneous semaglutide 2 mg once weekly can be transitioned to oral semaglutide 25 mg or 50 mg once daily.
Patients can start oral semaglutide (Rybelsus) one week after their last dose of subcutaneous semaglutide. When semaglutide is used in combination with metformin and/or a sodium-glucose co-transporter-2 inhibitor (SGLT2i) or thiazolidinedione, the current dose of metformin and/or SGLT2i or thiazolidinedione can be continued.
8). Self-monitoring of blood glucose is not needed in order to adjust the dose of semaglutide. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when semaglutide is started and insulin is reduced.
A stepwise approach to insulin reduction is recommended. Missed dose If a dose is missed, the missed dose should be skipped and the next dose should be taken the following day. Elderly No dose adjustment is required based on age. Renal impairment No dose adjustment is required for patients with mild, moderate or severe renal impairment.
Experience with the use of semaglutide in patients with end-stage kidney disease is limited. 2). Hepatic impairment No dose adjustment is required for patients with hepatic impairment. Experience with the use of semaglutide in patients with severe hepatic impairment is limited.
Summary of the safety profile In 10 phase 3a trials, 5 707 patients were exposed to semaglutide alone or in combination with other glucose-lowering medicinal products. The duration of the treatment ranged from 26 weeks to 8 78 weeks.
The most frequently reported adverse reactions in clinical trials were gastrointestinal disorders, including nausea (very common), diarrhoea (very common) and vomiting (common). 1) and post- marketing reports in patients with type 2 diabetes mellitus.
The frequencies of the adverse reactions (except diabetic retinopathy complications and dysaesthesia, see footnotes in Table 1) are based on a pool of the phase 3a trials excluding the cardiovascular outcomes trial. The reactions are listed below by system organ class and absolute frequency.
Frequencies are defined as: very common: (≥ 1/10); common: (≥ 1/100 to < 1/10); uncommon: (≥ 1/1 000 to < 1/100); rare: (≥ 1/10 000 to < 1/1 000) and very rare: (< 1/10 000); not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 0 mmol/L or < 54 mg/dL. b) Diabetic retinopathy complications are a composite of retinal photocoagulation, treatment with intravitreal agents, vitreous haemorrhage and diabetes-related blindness (uncommon).
Frequency is based on the cardiovascular outcomes trial with subcutaneous semaglutide, but it cannot be excluded that the risk of diabetic retinopathy complications identified also applies to Rybelsus. c) Grouped term covering also adverse events related to hypersensitivity such as rash and urticaria.
d) From post-marketing reports. e) The frequency is based on the PIONEER PLUS trial results for 25 mg and 50 mg. Please refer to dysaesthesia subheading below for more information. 5 mg, 4 mg and 9 mg respectively) in phase 3a trials, however, events have been reported in the post- marketing experience.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 5 General Semaglutide should not be used for the treatment of diabetic ketoacidosis.
2). 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. There is no therapeutic experience with semaglutide in patients with bariatric surgery.
Aspiration in association with general anaesthesia or deep sedation Cases of pulmonary aspiration have been reported in patients receiving GLP-1 receptor agonists undergoing general anaesthesia or deep sedation. 8) should be considered prior to performing procedures with general anaesthesia or deep sedation.
Gastrointestinal effects and dehydration Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. 8). Patients treated with semaglutide should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion.
Acute pancreatitis 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, semaglutide should be discontinued; if confirmed, semaglutide should not be restarted.
8). 2). 8). Caution should be exercised when using semaglutide in patients with diabetic retinopathy. These patients should be monitored closely and treated according to clinical guidelines. Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy, but other mechanisms cannot be excluded.
Long- term glycaemic control decreases the risk of diabetic retinopathy. There is no experience with oral semaglutide 25 mg and 50 mg in patients with type 2 diabetes with uncontrolled or potentially unstable diabetic retinopathy. Non-arteritic anterior ischaemic optic neuropathy (NAION) Data from epidemiological studies indicates an increased risk for non-arteritic anterior ischaemic optic neuropathy (NAION) during treatment with semaglutide.
1.
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2). Paediatric population The safety and efficacy of Rybelsus in children and adolescents below 18 years have not been established. No data are available. Method of administration Rybelsus is a tablet for once-daily oral use. 2). – It should be swallowed whole with a sip of water (up to half a glass of water equivalent to 120 mL).
Tablets should not be split, crushed or chewed, as it is not known whether this impacts absorption of semaglutide. – Patients should wait at least 30 minutes before eating, drinking or taking other oral medicinal products. 2).
f) Grouped term covering PTs ‘intestinal obstruction’, ‘ileus’, ‘small intestinal obstruction’. 013 events/patient year). 001 events/patient year) were observed with semaglutide in combination with oral antidiabetics other than sulfonylurea.
Gastrointestinal adverse reactions Nausea occurred in 15%, diarrhoea in 10%, and vomiting in 7% of patients when treated with semaglutide. Most events were mild to moderate in severity and of short duration. The events led to treatment discontinuation in 4% of subjects.
The events were most frequently reported during the first months on treatment. In PIONEER PLUS when treated with semaglutide 25 mg and 50 mg nausea occurred in 27% and 27%, diarrhoea in 13% and 14%, and vomiting in 17% and 18% of patients, respectively.
These events led to treatment discontinuation in 6% and 8% of patients, respectively. Most events were mild to moderate in severity and of short duration. The events were most frequently reported during dose escalation the first months on treatment.
Patients with gastroparesis may experience more serious or severe gastrointestinal effects when treated with semaglutide. 2%). ). 4% for placebo. Diabetic retinopathy complications A 2-year clinical trial with subcutaneous semaglutide investigated 3 297 patients with type 2 diabetes, with high cardiovascular risk, long duration of diabetes and poorly controlled blood glucose.
8%). This was observed in insulin-treated patients with known diabetic retinopathy. The treatment difference appeared early and persisted throughout the trial. Systematic evaluation of diabetic retinopathy complication was only performed in the cardiovascular outcomes trial with subcutaneous semaglutide.
In clinical trials with Rybelsus of up to 18 months duration involving 6 352 patients with type 2 diabetes, adverse events […]
There is no identified time interval for when NAION may develop following treatment start. 8). Patients with gastroparesis Semaglutide treated patients with gastroparesis may experience more serious or severe gastrointestinal adverse events.
8). Treatment response Compliance with the dosing regimen is recommended for optimal effect of semaglutide. If the treatment response with semaglutide is lower than expected, the treating physician should be aware that the absorption of semaglutide is highly variable and may be minimal (2-4% of patients will not have any exposure), and that the absolute bioavailability of semaglutide is low.
5 mg, 4 mg and 9 mg tablets: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. 25 mg and 50 mg tablets: 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.