Generic Name:
Semaglutide Injection (0.25 mg/0.5 mg/1 mg/1.7 mg/2.4 mg), solution for injection (r-DNA Origin) in pre-filled pen
Brand Name:
Wegovy® (FlexTouch®)
Presentation: Wegovy® FlexTouch® is available in 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg.
Indication:
Weight Management: Semaglutide Injection (Wegovy®) is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
Limitations of Use: Wegovy® should not be co-administered with other semaglutide containing products or with any other GLP- 1 receptor agonist. The safety and effectiveness of semaglutide in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. Wegovy® has not been studied in patients with a history of pancreatitis.
Established cardiovascular disease: Semaglutide Injection (Wegovy®) is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardi-ovascular disease and either obesity or overweight.
Description: Wegovy® is a clear and colourless solution for injection in pre-filled disposable pen.
Dosing and administration: The maintenance dose of semaglutide 2.4 mg once-weekly is reached by starting with a dose of 0.25 mg. To reduce the likelihood of gastrointestinal symptoms, the dose should be escalated over a 16-week period to a maintenance dose of 2.4 mg once weekly. In case of significant gastrointestinal symptoms, consider delaying dose escalation until symptoms have improved.
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. The day of weekly administration can be changed, if necessary, as long as the time between two 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 Wegovy®.
Special Population: No dose adjustment is required based on age. Therapeutic experience in patients ≥ 85 years of age is limited. 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. Semaglutide is not recommended for use in patients with severe renal impairment (eGFR <30 mL/min/1.73m2) including patients with end-stage renal disease. 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. Semaglutide is not recommended for use in patients with severe hepatic impairment and should be used cautiously in patients with mild or moderate hepatic impairment. The safety and efficacy of semaglutide in children below 12 years of age have not been established.
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Patients should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion. 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 re-started. 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. 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. 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. The addition of Wegovy® in patients treated with insulin has not been evaluated. In patients with diabetic retinopathy treated with 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 reti-nopathy, but other mechanisms cannot be excluded. Patients with diabetic retinopathy using semaglutide should be moni-tored 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.
Use in special populations (Fertility, pregnancy and lactation): Women of childbearing potential are recommended to use contraception when treated with semaglutide. There are limited data from the use of semaglutide in pregnant women. Therefore, semaglutide should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, semaglutide should be discontinued. Semaglutide should be discontinued at least 2 months before a planned pregnancy due to the long half-life. Semaglutide should not be used during breast-feeding. The effect of semaglutide on fertility in humans is unknown.
Drug Interaction: Semaglutide delays gastric emptying and could potentially influence the absorption of concomitantly ad-ministered oral medicinal products. No clinically relevant effect on the rate of gastric emptying was observed with semaglutide 2.4 mg, probably due to a tolerance effect. Semaglutide should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption.
Paracetamol: Semaglutide delays the rate of gastric emptying as assessed by paracetamol pharmacokinetics during a stand-ardised meal test. No clinically relevant effect on paracetamol was observed with semaglutide. No dose adjustment of para-cetamol is necessary when administered with semaglutide.
Oral contraceptives: Semaglutide is not anticipated to decrease the effectiveness of oral contraceptives as semaglutide did not change the overall exposure of ethinylestradiol and levonorgestrel to a clinically relevant degree, when an oral contracep-tive combination medicinal product (0.03 mg ethinylestradiol/0.15 mg levonorgestrel) was co-administered with semaglutide.
Atorvastatin: Semaglutide did not change the overall exposure of atorvastatin following a single dose administration of atorvastatin (40 mg). Atorvastatin Cmax was decreased by 38%. This was assessed not to be clinically relevant.
Digoxin: Semaglutide did not change the overall exposure or Cmax of digoxin following a single dose of digoxin (0.5 mg).
Metformin: Semaglutide did not change the overall exposure or Cmax of metformin following dosing of 500 mg twice daily over 3.5 days.
Warfarin & other coumarin derivatives: Semaglutide did not change overall exposure or Cmax of R- and S-warfarin following a single dose of warfarin (25 mg), and the pharmacodynamic effects of warfarin as measured by the international normalised ratio (INR) were not affected in a clinically relevant manner. However, cases of decreased INR have been reported during concomitant use of acenocoumarol and semaglutide. Upon initiation of semaglutide treatment in patients on warfarin or other coumarin derivatives, frequent monitoring of INR is recommended.
Undesirable Effects: In 4 phase 3a trials, 2,650 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. In general, these reactions were mild or moderate in severity and of short duration. Other undesirable effects being delayed gastric emptying, dysgeusia, dizziness and intestinal obstruction.
Shelf life: Before use: 36 months; After first use: 6 weeks. Store below 30°C or in a refrigerator (2°C to 8°C).
Storage: Keep this medicine out of the sight and reach of children. Store in a refrigerator (2°C to 8°C). Do not freeze and do not use Wegovy® if it has been frozen. After first use: Store below 30°C or in a refrigerator (2°C to 8°C). Keep the pen cap on when the pen is not in use in order to protect it from light. Always remove the injection needle after each injection and store the pen without a needle attached.
Disclaimer: The abbreviated package insert is updated from the CDSCO approved package insert (File no. BIO/IMP/24/000089 dated 25 Feb 2025). Wegovy® FlexTouch®, NovoFine® and Apis bull logo is a registered trademark owned by Novo Nordisk A/S and registered in Denmark. Imported by: Novo Nordisk India Private Limited, Bangalore.
*For full prescribing information, please contact +91-8040303200 or write to us at INAgree@novonordisk.com or reach us at Novo Nordisk India Pvt Ltd, NXT Tower-2, Floor 1&2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore – 560045, India.
