Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Ozempic is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
The starting dose is 0.25 mg semaglutide once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly to further improve glycaemic control.
Semaglutide 0.25 mg is not a maintenance dose. Weekly doses higher than 1 mg are not recommended.
When Ozempic is added to existing metformin and/or thiazolidinedione therapy, the current dose of metformin and/or thiazolidinedione can be continued unchanged.
When Ozempic is added to existing therapy of sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia (see sections 4.4 and 4.8).
Self-monitoring of blood glucose is not needed in order to adjust the dose of Ozempic. However, when initiating treatment with Ozempic in combination with a sulfonylurea or an insulin, blood glucose self-monitoring may become necessary to adjust the dose of the sulfonylurea or the insulin 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.
No dose adjustment is required based on age. Therapeutic experience in patients ≥75 years of age is limited (see section 5.2).
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. Semaglutide is not recommended for use in patients with end-stage renal disease (see section 5.2).
No dose adjustment is required for patients with hepatic impairment. Experience with the use of Semaglutide in patients with severe hepatic impairment is limited. Caution should be exercised when treating these patients with semaglutide (see section 5.2).
The safety and efficacy of semaglutide in children and adolescents below 18 years have not yet been established. No data are available.
Ozempic is to be administered once weekly at any time of the day, with or without meals.
Ozempic is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site can be changed without dose adjustment. Ozempic 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.
For further information on administration, see section 6.6.
Overdoses of up to 4 mg in a single dose, and up to 4 mg in a week have been reported in clinical trials. The most commonly reported adverse reaction was nausea. All patients recovered without complications.
There is no specific antidote for overdose with semaglutide. In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of semaglutide of approximately 1 week (see section 5.2).
3 years.
In-use shelf life: 6 weeks.
After first use: Store below 30°C or in a refrigerator (2°C to 8°C). Do not freeze Ozempic and do not use Ozempic if it has been frozen. 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. This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.
Before first use: Store in a refrigerator (2°C to 8°C). Keep away from the cooling element. Do not freeze Ozempic and do not use Ozempic if it has been frozen.
For storage conditions after first opening of the medicinal product, see section 6.3.
Keep the pen cap on in order to protect from light.
1.5 ml or 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:
Ozempic 0.25 mg solution for injection: Each pre-filled pen contains 1.5 ml of solution, delivering 4 doses of 0.25 mg. 1 pre-filled pen and 4 disposable NovoFine Plus needles.
Ozempic 0.5 mg solution for injection: Each pre-filled pen contains 1.5 ml of solution, delivering 4 doses of 0.5 mg. 1 pre-filled pen and 4 disposable NovoFine Plus needles. 3 pre-filled pens and 12 disposable NovoFine Plus needles.
Ozempic 1 mg solution for injection: Each pre-filled pen contains 3 ml of solution, delivering 4 doses of 1 mg. 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.
The patient should be advised to discard the injection needle after each injection and store the pen without an injection needle attached. This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing. Needles and other waste material should be disposed of in accordance with local requirements.
The pen is for use by one person only.
Ozempic should not be used if it does not appear clear and colourless or almost colourless.
Ozempic should not be used if it has been frozen.
Ozempic can be administered with needles up to a length of 8 mm. The pen is designed to be used with NovoFine or NovoTwist disposable needles. NovoFine Plus needles are included in the package.
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