VICTOZA® SOLUTION FOR INJECTION IN PRE-FILLED PEN 6MG/ML [SIN13905P]

Product Info

VICTOZA® SOLUTION FOR INJECTION IN PRE-FILLED PEN 6MG/ML

[SIN13905P]

4.1 Therapeutic indications
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

• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications

• in addition to other medicinal products for the treatment of diabetes (see Pharmacodynamic properties – Clinical efficacy and safety section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Prevention of cardiovascular events
Victoza is indicated as an adjunct to diet, exercise and standard care therapy to reduce the risk of major cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke) in adult patients with type 2 diabetes mellitus and established cardiovascular disease who have inadequate glycaemic control (see Pharmacodynamic properties – Clinical efficacy and safety section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration
Posology
Adults
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 during Ramadan when Victoza® is added to metformin for treatment of type 2 diabetes mellitus (see Other clinical data – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). It is recommended to finalise dose escalation of Victoza® before patients start Ramadan fasting.

Children aged 10 years and above
To improve gastro-intestinal tolerability, the starting dose is 0.6 mg liraglutide daily. After at least one week, the dose may be increased to 1.2 mg daily if additional glycaemic control is required. The dose can be increased to 1.8mg daily if required to further improve glycaemic control after at least one week of treatment with the 1.2mg daily dose.

Special populations
Elderly patients (>65 years old): No dose adjustment is required based on age (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment: 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment: 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population: No data are available for children below 10 years of age (see sections 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.