Rybelsus Adverse Reactions



Novo Nordisk


Zuellig Pharma


Novo Nordisk
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Full Prescribing Info
Adverse Reactions
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 78 weeks. The most frequently reported adverse reactions in clinical trials were gastrointestinal disorders, including nausea (very common), diarrhoea (very common) and vomiting (common).
Tabulated list of adverse reactions: Table 8 lists adverse reactions identified in all phase 3a trials in patients with type 2 diabetes mellitus (further described in Pharmacology: Pharmacodynamics under Actions). The frequencies of the adverse reactions are based on a pool of the phase 3a trials excluding the cardiovascular outcomes trial.
The reactions are listed as follows 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). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 8.)

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Description of selected adverse reactions: Hypoglycaemia: Severe hypoglycaemia was primarily observed when semaglutide was used with a sulfonylurea (<0.1% of subjects, <0.001 events/patient year) or insulin (1.1% of subjects, 0.013 events/patient year). Few episodes (0.1% of subjects, 0.001 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 of treatment.
Acute pancreatitis confirmed by adjudication has been reported in phase 3a trials, semaglutide (<0.1%) and comparator (0.2%). In the cardiovascular outcomes trial the frequency of acute pancreatitis confirmed by adjudication was 0.1% for semaglutide and 0.2% for placebo (see Precautions).
Diabetic retinopathy complications: A 2-year clinical trial with s.c. semaglutide investigated 3,297 patients with type 2 diabetes, with high cardiovascular risk, long duration of diabetes and poorly controlled blood glucose. In this trial, adjudicated events of diabetic retinopathy complications occurred in more patients treated with s.c. semaglutide (3.0%) compared to placebo (1.8%). 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 s.c. semaglutide. In clinical trials with Rybelsus of up to 18 months duration involving 6,352 patients with type 2 diabetes, adverse events related to diabetic retinopathy were reported in similar proportions in subjects treated with semaglutide (4.2%) and comparators (3.8%).
Immunogenicity: Consistent with the potential immunogenic properties of medicinal products containing proteins or peptides, patients may develop antibodies following treatment with semaglutide. The proportion of subjects tested positive for anti-semaglutide antibodies at any time point after baseline was low (0.5%) and no subjects had neutralising anti-semaglutide antibodies or anti-semaglutide antibodies with neutralising effect on endogenous GLP-1 at end-of-trial.
Heart rate increase: Increased heart rate has been observed with GLP-1 receptor agonists. In the phase 3a trials, mean changes of 0 to 4 beats per minute (bpm) from a baseline of 69 to 76 were observed in patients treated with Rybelsus.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
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