Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
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
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 (see Table 1). In case of significant gastrointestinal symptoms, consider delaying dose escalation or lowering to the previous dose until symptoms have improved.
Table 1. Dose escalation schedule:
| Dose escalation | Weekly dose |
|---|---|
| Week 1–4 | 0.25 mg |
| Week 5–8 | 0.5 mg |
| Week 9–12 | 1 mg |
| Week 13–16 | 1.7 mg |
| Maintenance dose | 2.4 mg |
Weekly doses higher than 2.4 mg are not recommended.
When initiating semaglutide in patients with type 2 diabetes, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia, see section 4.4.
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.
No dose adjustment is required based on age. Therapeutic experience in patients ≥75 years of age is limited, and greater sensitivity of some older individuals cannot be excluded.
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 (see sections 4.4, 4.8 and 5.2).
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 (see sections 4.4 and 5.2).
The safety and efficacy of semaglutide in children and adolescents below 18 years have not yet been established. No data are available.
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.
When administering Wegovy, the pen should be pressed firmly against the skin until the yellow bar has stopped moving. 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.
For further information before administration see section 6.6.
Overdose with semaglutide may be associated with gastrointestinal disorders which could lead to dehydration. In the event of overdose the patient should be observed for clinical signs and appropriate supportive treatment initiated.
24 months.
Wegovy may be stored unrefrigerated for up to 28 days at a temperature not above 30°C. Discard the pen if it has been out of the refrigerator for more than 28 days.
Store in a refrigerator (2°C-8°C). Keep away from the cooling element.
Do not freeze and do not use Wegovy if it has been frozen.
Store the pen in the original carton in order to protect from light.
1 mL glass syringe (type I glass) with attached stainless steel needle, rigid needle shield (type II/polyisoprene) and a rubber plunger (type I/chlorobutyl).
Pack sizes: 4 pre-filled pens.
The pen is for single-use only.
Wegovy should not be used if it does not appear clear and colourless.
The pen should not be used if it has been frozen.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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