Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark
Victoza is indicated for the treatment of adults, adolescents and children aged 10 years and above 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.
To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily. After at least one week, the dose should be increased to 1.2 mg. Some patients are expected to benefit from an increase in dose from 1.2 mg to 1.8 mg and based on clinical response, after at least one week, the dose can be increased to 1.8 mg to further improve glycaemic control. Daily doses higher than 1.8 mg are not recommended.
When Victoza is added to a sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia (see section 4.4). Combination therapy with sulfonylurea is only valid for adult patients.
Self-monitoring of blood glucose is not needed in order to adjust the dose of Victoza. Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when Victoza therapy is started and insulin is reduced. A stepwise approach to insulin dose reduction is recommended.
No dose adjustment is required based on age (see section 5.2).
No dose adjustment is required for patients with mild, moderate or severe renal impairment. There is no therapeutic experience in patients with end-stage renal disease, and Victoza is therefore not recommended for use in these patients (see sections 5.1 and 5.2).
No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Victoza is not recommended for use in patients with severe hepatic impairment (see section 5.2).
No dose adjustment is required for adolescents and children aged 10 years and above. No data are available for children below 10 years of age (see sections 5.1 and 5.2).
Victoza must not be administered intravenously or intramuscularly.
Victoza is administered once daily at any time, independent of meals, and can be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The injection site and timing can be changed without dose adjustment. However, it is preferable that Victoza is injected around the same time of the day, when the most convenient time of the day has been chosen. For further instructions on administration, see section 6.6.
From clinical trials and marketed use, overdoses have been reported of up to 40 times (72 mg) the recommended maintenance dose. Events reported included severe nausea, vomiting, diarrhoea and severe hypoglycaemia.
In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. The patient should be observed for clinical signs of dehydration and blood glucose should be monitored.
30 months.
After first use: 1 month.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Store away from the freezer compartment.
After first use: Store below 30°C or store in a refrigerator (2°C–8°C). Do not freeze.
Keep the cap on the pen in order to protect from light.
Cartridge (type 1 glass) with a plunger (bromobutyl) and a laminate rubber sheet (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polyolefin and polyacetal.
Each pen contains 3 ml solution, delivering 30 doses of 0.6 mg, 15 doses of 1.2 mg or 10 doses of 1.8 mg.
Pack sizes of 1, 2, 3, 5 or 10 pre-filled pens.
Not all pack sizes may be marketed.
Victoza should not be used if it does not appear clear and colourless or almost colourless.
Victoza should not be used if it has been frozen.
Victoza can be administered with needles up to a length of 8 mm and as thin as 32G. The pen is designed to be used with NovoFine or NovoTwist disposable needles.
Needles are not included.
The patient should be advised to discard the injection needle in accordance with local requirements after each injection and store the pen without an injection needle attached. This prevents contamination, infection and leakage. It also ensures that the dosing is accurate.
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