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Wegovy is a brand name for Semaglutide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of • ≥30 kg/m2 (obesity), or • ≥27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one…
Verbatim from this product's EMA label. Tap a section to expand.
25 mg. 4 mg once weekly (see Table 2). 4 mg dose in adults with BMI ≥ 30 kg/m2 at treatment initiation. 4 mg once weekly. In case of significant gastrointestinal symptoms, consider delaying dose escalation or lowering to the previous dose until symptoms have improved.
2 mg Adolescents For adolescents ages 12 years and above, the same dose escalation schedule as for adults should be applied (see Table 2). 4 mg (maintenance dose) or maximum tolerated dose has been reached. 4 mg are not recommended. 4.
5 Missed dose If a dose is missed, it should be administered as soon as possible and within 5 days after the missed dose. If more than 5 days have passed, the missed dose should be skipped, and the next dose should be administered on the regularly scheduled day.
In each case, patients can then resume their regular once weekly dosing schedule. If more doses are missed, reducing the starting dose for re-initiation should be considered. Special populations Elderly (≥65 years old) No dose adjustment is required based on age.
Therapeutic experience in patients ≥85 years of age is limited. Patients with renal impairment No dose adjustment is required for patients with mild or moderate renal impairment. Experience with the use of semaglutide in patients with severe renal impairment is limited.
2). Patients with hepatic impairment No dose adjustment is required for patients with mild or moderate hepatic impairment. Experience with the use of semaglutide in patients with severe hepatic impairment is limited. 2). Paediatric population No dose adjustment is required for adolescents ages 12 years and above.
4 mg are not recommended. The safety and efficacy of semaglutide in children below 12 years of age have not been established. Method of administration Subcutaneous use. Wegovy is administered once weekly at any time of the day, with or without meals.
It is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed. It should not be administered intravenously or intramuscularly. 4 mg one after each other. The injections can be administered in the same body area but should be at least 5 cm apart.
The day of weekly administration can be changed if necessary, as long as the time between doses is at least 3 days (>72 hours). After selecting a new dosing day, once-weekly dosing should be continued. When administering Wegovy pre-filled pen for single use, the pen should be pressed firmly against the skin until the yellow bar has stopped moving.
Summary of safety profile In four phase 3a trials, 2 650 adult patients were exposed to Wegovy. The duration of the trials were 68 weeks. The most frequently reported adverse reactions were gastrointestinal disorders including nausea, diarrhoea, constipation and vomiting.
Tabulated list of adverse reactions Table 3 lists adverse reactions identified in clinical trials in adults and post-marketing reports. The frequencies are based on a pool of the phase 3a trials. Adverse reactions associated with Wegovy are listed by system organ class and frequency.
Frequency categories 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); very rare (<1/10 000) and not known (cannot be estimated from the available data). Table 3 Frequency of adverse reactions of semaglutide MedDRA system organ class Very common Common Uncommon Rare Very Rare Not known Immune system disorders Anaphylact ic reaction Metabolism and nutrition disorders Hypoglycae mia in patients with type 2 diabetesa Nervous system disorders Headacheb Dizzinessb Dysgeusiab,c Dysaesthesia a,d Eye disorders Diabetic retinopathy in patients with type 2 diabetesa Non- arteritic anterior ischaemic optic neuropathy (NAION) Cardiac disorders Hypotension Orthostatic hypotension Increased heart ratea,c 10 MedDRA system organ class Very common Common Uncommon Rare Very Rare Not known Gastrointes tinal disorders Vomitinga,b Diarrhoeaa,b Constipatio na,b Nauseaa,b Abdominal painb,c Gastritisb,c Gastrooesop hageal reflux diseaseb Dyspepsiab Eructationb Flatulenceb Abdominal distensionb Acute pancreatitisa Delayed gastric emptying Intestinal obstructio n Hepatobilia ry disorders Cholelithiasi sa Skin and subcutaneo us tissue disorders Hair lossa Angioedem a General disorders and administrati on site conditions Fatigueb,c Injection site reactionsc Investigatio ns Increased amylasec Increased lipasec a) see description of selected adverse reactions below b) mainly seen in the dose-escalation period c) Grouped preferred terms d) Frequency is based on the 3a program.
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. 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.
8). 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. Caution should be exercised in patients with a history of pancreatitis.
In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis. 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.
There is no identified time interval for when NAION may develop following treatment start. 8). Patients with type 2 diabetes Semaglutide should not be used as a substitute for insulin in patients with type 2 diabetes. Semaglutide should not be used in combination with other GLP-1 receptor agonist products.
It has not been evaluated and an increased risk of adverse reactions related to overdose is considered likely. Hypoglycaemia in patients with type 2 diabetes Insulin and sulfonylurea are known to cause hypoglycaemia. Patients treated with semaglutide in combination with a sulfonylurea or insulin may have an increased risk of hypoglycaemia.
1. 6
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The injection takes about 5–10 seconds. Patients should be advised to read the instruction for use included in the package leaflet carefully before administering the medicinal product. 6.
2 mg dose. Please refer to dysaesthesia subheading below for more information. Description of selected adverse reactions The below information on specific adverse reactions, unless otherwise specified, pertains to the phase 3a trials.
3% for placebo). Most events were mild to moderate in severity and of short duration. 1% for placebo) and was mild to moderate in severity and of longer duration. In patients treated with semaglutide, median duration of nausea was 8 days, vomiting 2 days, diarrhoea 3 days, and constipation 47 days.
73m2) may experience more gastrointestinal effects when treated with semaglutide. 3% of patients. Patients with gastroparesis may experience more serious or severe gastrointestinal effects when treated with semaglutide. 1% for placebo, respectively.
3% for placebo. 6% of patients treated with semaglutide. 3%, respectively, of patients treated with placebo. 0% of patients treated with placebo. 0% of patients on placebo. The events were mainly of mild severity and most patients recovered while on continued treatment.
Hair loss was reported more frequently in patients with a greater weight loss (≥20%). Increased heart rate In the phase 3a trials, a mean increase of 3 beats per minute (bpm) from a baseline mean of 72 bpm was observed in patients treated with semaglutide.
0% in the semaglutide group vs. 1% in the placebo group. Immunogenicity Consistent with the potentially immunogenic properties of medicinal products containing proteins or peptides, patients may develop antibodies following treatment with semaglutide.
2 mg. No patients had anti-semaglutide neutralising antibodies or anti-semaglutide antibodies with endogenous GLP-1 neutralising effect. During treatment, high semaglutide concentrations might have lowered the sensitivity of the assays, hence the risk of false negatives cannot be excluded.
However, in subjects testing positive for antibodies during and after treatment, the presence of antibodies was transient and with no apparent impact on efficacy and safety. 03 events/patient year) of subjects treated with placebo. Hypoglycaemia with semaglutide was seen both with and without concomitant use of sulfonylurea.
002 events/patient year) was reported as […]
The risk of hypoglycaemia can be lowered by reducing the dose of sulfonylurea or insulin when initiating treatment with a GLP-1 receptor agonist. 8). Rapid improvement in glucose control 7 has been associated with a temporary worsening of diabetic retinopathy, but other mechanisms cannot be excluded.
Patients with diabetic retinopathy using semaglutide should be monitored closely and treated according to clinical guidelines. There is no experience with Wegovy in patients with type 2 diabetes with uncontrolled or potentially unstable diabetic retinopathy.
In these patients, treatment with Wegovy is not recommended. Patients with gastroparesis Semaglutide treated patients with gastroparesis may experience more serious or severe gastrointestinal adverse events. 8). 2), – with congestive heart failure New York Heart Association (NYHA) class IV.
Use in these patients is not recommended. 2), – with inflammatory bowel disease. Use with caution in these patients. Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.