WEGOVY Solution for injection Ref.[49657] Active ingredients: Semaglutide

Posology

Adults

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 2). In case of significant gastrointestinal symptoms, consider delaying dose escalation or lowering to the previous dose until symptoms have improved. Weekly doses higher than 2.4 mg are not recommended.

Table 2. Dose escalation schedule:

Adolescents

For adolescents ages 12 years and above, the same dose escalation schedule as for adults should be applied (see Table 2). The dose should be increased until 2.4 mg (maintenance dose) or maximum tolerated dose has been reached. Weekly doses higher than 2.4 mg are not recommended.

Patients with type 2 diabetes

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.

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 ≥75 years of age is limited, and greater sensitivity of some older individuals cannot be excluded.

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. 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).

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. 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).

Paediatric population

No dose adjustment is required for adolescents ages 12 years and above. 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.

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 pre-filled pen for single use, 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.

Pre-filled pen, single-dose:

1 year.

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.

Pre-filled pen, FlexTouch:

Wegovy 0.25 mg FlexTouch solution for injection in pre-filled pen

Before use: 2 years.

After first use: 6 weeks. Store below 30°C or in a refrigerator (2°C to 8°C).

Wegovy 0.5 mg FlexTouch solution for injection in pre-filled pen
Wegovy 1 mg FlexTouch solution for injection in pre-filled pen
Wegovy 1.7 mg FlexTouch solution for injection in pre-filled pen
Wegovy 2.4 mg FlexTouch solution for injection in pre-filled pen

Before use: 3 years.

After first use: 6 weeks. Store below 30°C or in a refrigerator (2°C to 8°C).

Store in a refrigerator (2°C-8°C). Keep away from the cooling element.

Do not freeze.

Pre-filled pen, single-dose:

Store the pen in the original carton in order to protect from light.

Pre-filled pen, FlexTouch:

Keep the pen cap on when the pen is not in use in order to protect it from light.

Pre-filled pen, single-dose:

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).

Pre-filled pen, FlexTouch (0.25, 0.5 mg) 1.5 mL pre-filled pen:

1.5 mL glass cartridge (type I glass) closed at the one end with a rubber plunger (chlorobutyl) and at the other end with an aluminium cap with a laminated rubber sheet (bromobutyl/polyisoprene) inserted. The cartridge is assembled into a disposable pre-filled pen made of polypropylene, polyoxymethylene, polycarbonate and acrylonitrile butadiene styrene.

Pre-filled pen, FlexTouch (0.5 1, 1.7 and 2.4 mg) 3 mL pre-filled pen:

3 mL glass cartridge (type I glass) closed at the one end with a rubber plunger (chlorobutyl) and at the other end with an aluminium cap with a laminated rubber sheet (bromobutyl/polyisoprene) inserted.

The cartridge is assembled into a disposable pre-filled pen made of polypropylene, polyoxymethylene, polycarbonate and acrylonitrile butadiene styrene.

Pack sizes:

Pre-filled pen, single-dose (0.25, 0.5, 1, 1.7 and 2.4 mg)

Pack size of 4 pre-filled pens.

Pre-filled pen, FlexTouch (0.25, 0.5, 1 and 1.7 mg)

Pack size of 1 pre-filled pen and 4 disposable NovoFine Plus needles.

Pre-filled pen, FlexTouch (2.4 mg)

Pack sizes:

1 pre-filled pen and 4 disposable NovoFine Plus needles.
3 pre-filled pens and 12 disposable NovoFine Plus needles.

Not all pack sizes may be marketed.

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.

Pre-filled pen, single-dose:

The pen is for single-dose only.

Pre-filled pen, FlexTouch:

This pen is for multi-use. It contains 4 doses.

The patient should be advised to discard the injection needle in accordance with local requirements after each injection and store the Wegovy pen without an injection needle attached. This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.

The pen is for use by one person only.

Wegovy can be administered with 30G, 31G, and 32G disposable needles up to a length of 8 mm.