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

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

INJECTION, SOLUTION

**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 _Special warnings and precautions for use_ – _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 1.8 mg daily if required to further improve glycaemic control after at least one week of treatment with the 1.2 mg daily dose. **_Special populations_** _Elderly patients (>65 years old):_ No dose adjustment is required based on age (see _Pharmacokinetic properties_ – _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 _Pharmacodynamic properties_ and _Pharmacokinetic properties_ – _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 _Pharmacokinetic properties_ – _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 _Pharmacodynamic properties_ and _Pharmacokinetic properties_ – _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 _Special precautions for disposal and other handling_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).