Victoza® launched in Malta

23rd May 2016

Dear Doctor,

Novo Nordisk is pleased to announce the availability of Victoza® ( Liraglutide) in Malta. Victoza® is indicated for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control.

Liraglutide is a once-daily analogue of the human native hormone GLP-1 for the treatment of type 2 diabetes. In addition to glycaemic control with a very low rate of hypoglycaemia, Victoza® significantly reduces body weight, hypertension, and improves lipid profiles and several cardiovascular risk markers.

Information on the Victoza® can be found below.

Please contact the local medical representative for further information on 99241466.

Best regards,

Petra Spiteri

 

 

 

 

 

 

 

 

 

References:1. Internal calculations based on IMS Health MIDAS Database, September 2015
2. Pratley R, Nauck M, Bailey T, et al; for the 1960 –LIRA-DPP4 Study Group. One year of Liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel group, open label trial. Int J ClinPract; 2011; 65 (4):397-407
3. Pratley RE, Nauck M, Bailet et al; for the 1860- LIRA-DPP4 Study Group. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate control with metformin: a 26 week, randomised, parallel- group open –label trial. Lancet 2010;375 (92724):1447-1457.
4. Victoza ® summary of product characteristics. Bagsvaerd, Denmark:Novo Nordisk A/S:2015
5. Kendall DM, Cuddihy RM, Bergenstal RM. Clinical application of incretin-based therapy: therapeutic potential, patient selection and clinical use. Am J Med. Vol 122, No 6A, June 2009.
6. Flint A, Kapitza C, Zdravkovic M. The once-daily human GLP-1 analogue liraglutide impacts appetite and energy intake in patients with type 2 diabetes after short-term treatment. Diabetes Obes Metab. 2013;15(10): 958-962.
7. Chang AM, Jakobsen G, Sturis J, et al. The GLP-1 derivative NN2211 restores β-cell sensitivity to glucose in type 2 diabetic patients after a single dose. Diabetes. 2003;52(7):1786-1791.
8. DeFronzo RA. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58(4):773–795

Prescribing Information
Victoza® Liraglutide.
Presentation: Prefilled disposable pen containing 18 mg of liraglutide in 3 mL of solution. Indications: Victoza® is indicated for treatment of adults with type 2 diabetes to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. Dosage and administration: The starting dose is 0.6 mg 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. Therapeutic experience in patients ≥75 years of age is limited. Victoza® can be used without dose adjustment in patients with mild or moderate renal impairment (creatinine clearance 60–90 ml/min and 30–59 ml/min, respectively). Victoza® can currently not be recommended for use in patients with severe renal impairment or hepatic impairment. The therapeutic experience in patients with all degrees of hepatic impairment is currently too limited to recommend the use in patients with mild, moderate or severe hepatic impairment. In combination with metformin with or without a thiazolidinedione, no dose adjustment is required. When Victoza® is added to sulphonylurea therapy or a basal insulin, a reduction in the dose of sulphonylurea or basal insulin should be considered to reduce the risk of hypoglycaemia. Method of administration: Victoza® should 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, thigh, or upper arm. Contraindications: Hypersensitivity to the active substance or any of the excipients. Special warnings and precautions: Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Victoza® is not a substitute for insulin. Due to limited experience, Victoza® is not recommended in patients with inflammatory bowel disease or diabetic gastroparesis. There is 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. Use of GLP-1 receptor agonists has been associated with the risk of developing acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis. If pancreatitis is suspected, Victoza® should be discontinued; if acute pancreatitis is confirmed, Victoza® should not be restarted. Thyroid adverse events, including increased blood calcitonin, goitre, and thyroid neoplasm, were reported in clinical trials, particularly in patients with pre-existing thyroid disease. Patients receiving liraglutide in combination with a sulfonylurea or a basal insulin may have an increased risk of hypoglycaemia. Patients treated with Victoza® should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion. Fertility, pregnancy and lactation: Victoza® should not be used in women who are pregnant, who wish to become pregnant, or who are breastfeeding. Apart from a slight decrease in the number of live implants, animal studies did not indicate harmful effects with respect to fertility. Undesirable effects: The most frequently reported adverse reactions in patients treated with Victoza® are nausea and diarrhoea. Less common adverse reactions include headache, vomiting, dyspepsia, abdominal pain upper, constipation, gastritis, flatulence, abdominal distension, gastroesophageal reflux disease, bronchitis, nasopharyngitis, dizziness, fatigue, anorexia, decreased appetite, injection site reactions, abdominal discomfort, toothache, rash, increased heart rate, and hypoglycaemia. Since the market introduction of Victoza®, allergic reactions and dehydration (sometimes with a decrease in kidney function) have been reported. Patients receiving Victoza® in combination with a sulphonylurea or a basal insulin may have an increased risk of hypoglycaemia. The risk can be lowered by a reduction in the dose of sulphonylurea. Few cases (less than 0.2%) of acute pancreatitis have been reported during long-term clinical trials with Victoza®. Pancreatitis was also reported post-marketing. Overdose: From clinical trials and marketed use overdoses have been reported up to 40 times (72 mg) the recommended maintenance dose. Generally, the patients reported severe nausea, vomiting and diarrhoea. None of the patients reported severe hypoglycaemia. All patients recovered without complications. Marketing authorisation Holder: Novo Nordisk A/S- Novo Allé, DK-2880 Bagsværd, Denmark. Marketing authorisation numbers: EU/1/09/529/002 (2 pens x 3 mL). Classification for supply: Medicinal product subject to medical prescription. Date of revision: April 2016.

Suspected adverse reactions and medications errors should be reported. Report forms can be downloaded from www.medicinesauthority.gov.mt and sent by post or email to: P: ADR reporting The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue D’Argens, GŻR-1368 Gżira; E: postlicensing.medicinesauthority@gov.mt

Public Price: €107.90

Protocol number IT/VIC/0516/0074