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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: Weight management 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…
Verbatim from this product's MHRA label. Tap a section to expand.
25 mg. 4 mg once weekly (see Table 1). 4 mg dose. In case of significant gastrointestinal symptoms, consider delaying dose escalation or lowering to the previous dose until symptoms have improved. 1). Adolescents For adolescents ages 12 years and above, the same dose escalation schedule as for adults should be applied (see Table 1).
4 mg (maintenance dose) or maximum tolerated dose has been reached. 4 mg are not recommended. 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 Patients with type 2 diabetes Semaglutide should not be used in combination with other GLP-1 receptor agonist products.
When initiating semaglutide, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia. Elderly patients (≥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, moderate or severe 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 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 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, depending on the device. 2 mg solution for injection in pre-filled pen for single use, the pen should be pressed firmly against the skin until the yellow bar has stopped moving.
4 mg. The duration of the trials was 68 weeks. Similar to other GLP-1 receptor agonists, the most frequently reported adverse reactions were gastrointestinal disorders including nausea, diarrhoea, constipation and vomiting. Tabulated list of adverse reactions Table 2 lists adverse reactions identified in clinical trials in adults, the SELECT trial and post-marketing reports.
The frequencies are based on a pool of the phase 3a trials. 4 mg 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 2 Frequency of adverse reactions of semaglutide MedDRA system organ class Very common Common Uncommon Rare Very rare Not known Immune system disorders Anaphylactic reaction Metabolism and nutrition disorders Hypoglycaemia in patients with type 2 diabetesa Hypoglycaemia in patients without type 2 diabetesa Nervous system disorders Headacheb Dizzinessb Dysaesthesiaa,c, f Dysgeusiab,c Eye disorders Diabetic retinopathy in patients with type 2 diabetesa Non- arteritic anterior ischaemic optic neuropathy (NAION) Cardiac disorders Increased heart ratea,c Vascular disorders Hypotension Orthostatic hypotension Gastrointestinal disorders Vomitinga,b Diarrhoeaa,b Constipation a,b Nauseaa,b Abdominal painb, c Gastritisb, c Gastrooesophageal reflux diseaseb Dyspepsiab Eructationb Flatulenceb Abdominal distensionb Acute pancreatitisa Delayed gastric emptying Intestinal obstruction c,d,e Hepatobiliary disorders Cholelithiasisa Renal and urinary disorders Urolithiasis Skin and subcutaneous tissue disorders Hair lossa Angioedema General disorders and administration site conditions Fatigueb,c Injection site reactionsc Investigations Increased amylasec Increased lipasec Increased Bilirubina Injury Hip Fracturea a) See description of selected adverse reactions below b) Mainly seen in the dose-escalation period c) Grouped preferred terms d) From post-marketing reports e) Grouped term covering PTs Intestinal obstruction, Ileus, small intestinal obstruction f) Frequency is based on the 3a program.
Gastrointestinal effects and Dehydration Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. 8). Patientstreated with semaglutide shouldbeadvised of the potential risk of dehydrationin relation to gastrointestinal side effects and take precautions to avoid fluid depletion.
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.
Acute pancreatitis Semaglutide has not been studied in patients with a history of pancreatitis, and should be used with caution in these patients. Acute pancreatitis has been reported in patients treated with GLP-1 receptor agonists.
This includes post-marketing reports of necrotising pancreatitis and reports with a fatal outcome. Patients should be informed of the symptoms of acute pancreatitis, including persistent, severe abdominal pain. Patients should be advised to seek immediate medical attention if they occur.
If pancreatitis is suspected, semaglutide should be discontinued. If the diagnosis of pancreatitis is confirmed, semaglutide should not be restarted. 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 may indicate an increased risk of 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). For patients with diabetes Semaglutide must not be used as a substitute for insulin in patients with diabetes. Hypoglycaemia Semaglutide lowers blood glucose and can cause hypoglycaemia. Patients should be aware of the risk of hypoglycaemia and be educated on the signs and symptoms of hypoglycaemia.
1.
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. 4 mg, the injections can be given in the same body area but should be at least 5 cm apart - doses from more than one pen may need to be used and the needle should be changed between each dose.
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. 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. 1). Safety data collection was limited to serious adverse events (including death), adverse events leading to discontinuation, and adverse events of special interest.
Sixteen percent (16%) of Wegovy-treated patients and 8% of placebo-treated patients, respectively, discontinued study drug due to an adverse event. Additional information from this trial is included in subsequent sections below when relevant.
In the HFpEF trials, in adults with obesity related heart failure with preserved ejection fraction (HFpEF), the adverse reaction profile was similar to that seen in the weight management phase 3a trials. Description of selected adverse reactions Gastrointestinal adverse reactions The events were most frequently reported during dose escalation.
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. 3% of patients. In STEP UP trials gastrointestinal events were most frequently reported during dose escalation (during the initial 20 weeks of treatment).
7% for placebo). Most events were mild to moderate in severity and of short duration. 6% for placebo) and was mild to moderate in severity and of longer duration. 2% of patients. Patients with gastroparesis may experience more serious or severe gastrointestinal effects when treated with semaglutide.
1% for placebo, respectively. 4 mg. 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%).
4 mg. 6% in the placebo group. Immunogenicity Consistent with the potentially immunogenic properties of medicinal products containing […]
In patients with 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. The risk of hypoglycaemia can be lowered by reducing the dose of sulfonylurea or insulin when initiating treatment with a GLP- 1 receptor agonist.
Diabetic retinopathy in patients with type 2 diabetes In patients with diabetic retinopathy treated with insulin and semaglutide, an increased risk of developing diabetic retinopathy complications has been observed. Rapid improvement in glucose control 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. 4 mg in patients with type 2 diabetes with uncontrolled or potentially unstable diabetic retinopathy. Patients with gastroparesis Semaglutide treated patients with gastroparesis may experience more serious or severe gastrointestinal adverse events.
8). Populations not studied There is no experience in patients with congestive heart failure New York Heart Association (NYHA) class IV. There is limited experience in patients aged 85 years or more. e. essentially ‘sodium-free’. 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.