Victoza® solution for injection in pre-filled pen 6mg/ml

Novo Nordisk A/S (DENMARK)Novo Nordisk Pharmaceutical Industries, LP (UNITED STATES)🇸🇬 Health Sciences Authority

Approval Date: Dec 30, 2010
Approval ID: b1de5b53d3d3ee6c
Company: Novo Nordisk A/S (DENMARK)Novo Nordisk Pharmaceutical Industries, LP (UNITED STATES)
Type: Therapeutic

Approval Details

Approval Id: b1de5b53d3d3ee6c
Drug Name: Victoza® solution for injection in pre-filled pen 6mg/ml
Product Name: Victoza® solution for injection in pre-filled pen 6mg/ml
Approval Number: SIN13905P
Approval Date: 2010-12-30
Registrant: NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Licence Holder: NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: INJECTION, SOLUTION
Dosage: 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. Injection sites should always be rotated in order to reduce the risk of injection site amyloid deposits (see section and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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).
Route Of Administration: SUBCUTANEOUS
Indication Info: 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 <ul> <li>as monotherapy when metformin is considered inappropriate due to intolerance or contraindications</li> <li>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).</li> </ul> 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).
Contraindications: 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.
Atc Code: A10BJ02
Atc Item Name: liraglutide
Pharma Manufacturer Name: NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Active Ingredients

Liraglutide

6mg/ml

LIRAGLUTIDE

6 MG/ML

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Dec 30, 2010

Approval ID

b1de5b53d3d3ee6c

Type

Therapeutic

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