Ozempik –

The most frequently reported adverse reactions (ARs) during clinical trials were gastrointestinal (GI) disorders, including nausea, diarrhea, and vomiting. In general, these reactions were mild or moderate in severity and short-lived.
ARs are categorized according to MedDRA system organ classes and their frequency is reported according to WHO recommendations: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); and very rare (< 1/10,000). Within each frequency grouping, ARs are presented in order of decreasing seriousness.
^aHypoglycemia, defined as severe (requiring assistance) or symptomatic in combination with low blood glucose concentration.
Diabetic retinopathy complications include: the need for retinal photocoagulation, the need for intravitreal injections, vitreous hemorrhage, and the development of diabetes-related blindness.
Frequency is based on the cardiovascular (CV) outcomes trial. 2-year CV outcomes and safety trial In the population of patients at high risk of CV events, the AR profile was similar to that in other Phase 3 clinical trials. Description of individual ARs
Hypoglycemia During Ozempic® monotherapy, no episodes of severe hypoglycemia were observed. Severe hypoglycemia was mainly observed when Ozempic® was used in combination with a sulfonylurea derivative or insulin. Several episodes of severe hypoglycemia were observed when Ozempic® was used in combination with other GLP-1 receptor agonists, excluding sulfonylurea derivatives.
Gastrointestinal (GI) ARs During treatment with Ozempic® at doses of 0.5 mg and 1 mg, patients experienced nausea, diarrhea, and vomiting. Most reactions were mild to moderate in severity and short-lived. ARs led to premature discontinuation of the clinical trial in 3.9% and 5.9% of patients, respectively. ARs were most frequently reported in the first months of therapy.
Diabetic Retinopathy Complications In a 2-year clinical trial involving patients with type 2 diabetes and a high CV risk, a longer duration of diabetes, and inadequate glycemic control, confirmed cases of diabetic retinopathy complications developed in a greater number of patients receiving Ozempic® (3.0%) compared to patients receiving placebo (1.8%). In patients with a history of diabetic retinopathy at baseline, the increase in absolute risk of complications was higher. In patients without a confirmed history of diabetic retinopathy, the number of events was similar with Ozempic® and placebo.
In clinical trials lasting up to 1 year, the frequency of ARs related to diabetic retinopathy was similar in the Ozempic® group and comparator groups.
Treatment discontinuation due to ARs The rate of treatment discontinuation due to ARs was 8.7% for patients receiving Ozempic® 1 mg. The most common ARs leading to treatment discontinuation were GI disorders.
Injection Site Reactions Injection site reactions (such as injection site rash, redness) were reported in 0.6% and 0.5% of patients receiving semaglutide 0.5 mg and 1 mg, respectively. These reactions were generally mild.
Immunogenicity Due to the potential immunogenic properties of protein and peptide drugs, patients may develop antibodies to semaglutide after treatment with Ozempic®. At the end of the clinical trials, the proportion of patients with detectable semaglutide antibodies at any time point was low (1-2%), and no patients had detectable neutralizing antibodies to semaglutide or antibodies with a neutralizing effect on endogenous GLP-1.