Victoza Injection Solution 6 mg/1 ml 3 ml syringe-pen #2

International Nonproprietary Name - liraglutide Description Qualitative and quantitative composition One ml of solution contains 6 mg of liraglutide*. One pre-filled pen contains 18 mg of liraglutide in 3 ml. *An analogue of human glucagon-like peptide-1 (GLP-1) produced by recombinant DNA technology in Saccharomyces cerevisiae. For a full list of excipients, see pharmaceutical particulars. Dosage form Solution for injection, in a pre-filled pen. A clear, colorless, isotonic solution; pH=8.15. Clinical particulars Therapeutic indications VICTOZA® is used for the treatment of type 2 diabetes mellitus when diet and exercise alone are not sufficient to control blood sugar levels. VICTOZA® may be used in combination with other antidiabetic drugs, such as metformin, sulfonylurea (e.g., glimepiride or glibenclamide), metformin and sulfonylurea (e.g., glimepiride or glibenclamide), as well as metformin and thiazolidinedione (e.g., rosiglitazone or pioglitazone). Combination therapy with basal insulin for patients in whom adequate glycemic control cannot be achieved with VICTOZA® and metformin. Dosage and administration Dosage The starting dose is 0.6 mg of liraglutide per day. After at least one week, the dose should be increased to 1.2 mg. For some patients, it is expected that an increase from 1.2 mg to 1.8 mg will be beneficial and, depending on the clinical response and further improvement of glycemic control, the dose may be increased to 1.8 mg after at least one week. Daily doses higher than 1.8 mg are not recommended. VICTOZA® may be added to metformin or to combination therapy with metformin and thiazolidinedione. The existing dose of metformin and thiazolidinedione may remain unchanged. VICTOZA® may be added to sulfonylurea or to combination therapy with metformin and sulfonylurea. When VICTOZA® is added to treatment with sulfonylurea, a reduction in the dose of sulfonylurea should be considered to reduce the risk of hypoglycemia (see Special warnings and precautions for use). Self-monitoring of blood glucose is not required for dose adjustment of VICTOZA®. However, when VICTOZA® is prescribed in combination with sulfonylurea, self-monitoring of blood glucose may be necessary for dose adjustment of sulfonylurea at the beginning of treatment. Method of administration VICTOZA® is administered once daily, at any time, independently of meals, and can be injected subcutaneously into the abdominal area, thigh, or upper arm. The injection site and time can be changed without dose adjustment. However, it is preferable to administer the VICTOZA® injection at approximately the same time each day, at the time of day that is most convenient for you. For additional instructions for use, see section "Special precautions for disposal and other handling". VICTOZA® should not be administered intravenously or intramuscularly. Contraindications Hypersensitivity to the active substance or to any of the excipients. VICTOZA® must not be used during pregnancy, whereas insulin is recommended. If the patient wishes to become pregnant or has become pregnant, treatment with VICTOZA® should be discontinued.