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Victoza®▼ 6 mg/ml solution for injection in pre-filled pen
liraglutide
Victoza® 3 ml pen
1 ml of solution contains 6 mg of liraglutide.
Indication: Treatment of adults with type 2 diabetes mellitus in combination with
metformin or a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of metformin or sulphonylurea monotherapy; or in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy
Dosage: Victoza® is administered once daily by subcutaneous injection and can be
administered at any time independent of meals however, it is preferable that Victoza® is
injected around the same time of the day. Victoza® should not be administered intravenously or intramuscularly. Recommended starting dose is 0.6 mg liraglutide daily. After at least one week, the dose should be increased to a maintenance dose of 1.2 mg. Based on clinical response, after at least one week the dose can be increased to 1.8 mg to further improve glycaemic control in some patients. Daily doses higher than 1.8 mg are not recommended. When used with existing metformin therapy or in combination with metformin and thiazolidinedione therapy, the current dose of metformin and thiazolidinedione can continue unchanged. When added to existing sulphonylurea therapy or in combination with metformin and sulphonylureas, a reduction in the dose of sulphonylurea may be necessary to reduce the risk of hypoglycaemia. Victoza® can be used in the elderly (>65 years old) without dose adjustment but therapeutic experience in patients ≥75 years of age is limited. No dose adjustment is required for patients with mild renal impairment (creatinine clearance ≤60-90 ml/min). Due to lack of therapeutic experience Victoza® is not to be recommended for use in patients with moderate (creatinine clearance of 30-59 ml/min) and severe renal impairment (creatinine clearance below 30 ml/min) including patients with end-stage renal disease or patients
with hepatic impairment or children below 18 years of age.
Contraindications: Hypersensitivity to the active substance or any of the excipients.
Warnings and Precautions for use: Victoza® should not be used in patients with type
1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Limited experience in
patients with congestive heart failure New York Heart Association (NYHA) class I-II and no experience in patients with NYHA class III-IV. Due to limited experience Victoza® is not recommended for patients with inflammatory bowel disease and diabetic gastroparesis. Victoza® is associated with transient gastrointestinal adverse reactions, including nausea, vomiting and diarrhoea. Other GLP-1 analogues have been associated with pancreatitis; patients should be informed of symptoms of acute pancreatitis: persistent, severe abdominal pain; if pancreatitis suspected, Victoza® and other suspect medicinal products should be discontinued. Thyroid adverse events, including increased blood calcitonin, goitre and thyroid neoplasm reported in clinical trials particularly in patients with pre-existing thyroid disease. Risk of hypoglycaemia in combination with sulphonylureas; lowered by dose reduction of sulphonylurea. No studies on the effects on the ability to drive and use machines performed. Patients advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Victoza® is used in combination with a sulphonylurea. Substances added to Victoza® may cause degradation; in the absence of compatibility studies Victoza® must not be mixed with other medicinal products. Victoza Prescribing information – UK/LR/0409/0075 V1 Pregnancy and lactation: Victoza® should not be used during pregnancy or during
breast-feeding. If a patient wishes to become pregnant, or pregnancy occurs, treatment
with Victoza® should be discontinued; use of insulin is recommended instead.
Undesirable effects:
During clinical trials with Victoza® the most frequently observed adverse reactions which
varied according to the combination used (sulphonylurea, metformin or a thiazolidinedione) were: Very common: nausea, diarrhoea, hypoglycaemia when used in combination with a sulphonylurea and headache when used in combination with metformin; Common: vomiting, constipation, abdominal pain, discomfort and distension, dyspepsia, gastritis, flatulence, gastroesophageal reflux disease, gastroenteritis viral, toothache, headache, dizziness, nasopharyngitis, bronchitis, anorexia, appetite decreased, fatigue and pyrexia. Gastrointestinal adverse reactions are more frequent at start of therapy but are usually transient. Very few hypoglycaemic episodes observed other than with sulphonylureas. Patients >70 years or with mild renal impairment (creatinine clearance ≤60-90 ml/min) may experience more gastrointestinal effects. Consistent with medicinal products containing proteins/peptides, patients may develop anti-liraglutide antibodies following treatment but this has not been associated with reduced efficacy of Victoza®. Few cases reported of angioedema (0.05%), acute pancreatitis (<0.2%) and injection site reactions (approx. 2%). Injection site reactions usually mild; causal relationship between Victoza® and pancreatitis can neither be established nor excluded. Thyroid neoplasms, increased blood calcitonin and goitres are the most frequently thyroid adverse events and were reported in 0.5%, 1% and 0.8% of patients respectively. The Summary of Product Characteristics should be consulted for a
MA numbers: Victoza® 2 x 3ml pre-filled pens

Legal Category: POM

Basic NHS Price: Victoza® 2 x 3ml pre-filled pens

Further prescribing information can be obtained from:
Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, West Sussex, RH11 9RT.

Date created: June 2009

Adverse events should be reported. Reporting forms and information can be
found at se events should also be reported to
Novo Nordisk Limited (Telephone Novo Nordisk Customer Care Centre 0845
6005055). Calls may be monitored for training purposes.

Victoza® is a trademark owned by Novo Nordisk A/S.
Victoza Prescribing information – UK/LR/0409/0075 V1

Source: http://novomedlink.co.uk/files/pdf/pi/Victoza_PI.pdf