Victoza is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise 

• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
• in addition to other medicinal products for the treatment of diabetes.

Posology and method of administration

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. 

Victoza can be added to existing metformin or to a combination of metformin and thiazolidinedione therapy. The current dose of metformin and thiazolidinedione can be continued unchanged.

Victoza can be added to existing sulfonylurea or to a combination of metformin and sulfonylurea therapy or insulin. When Victoza is added to sulfonylurea therapy or insulin, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia.

Self-monitoring of blood glucose is not needed in order to adjust the dose of Victoze. However, when initiating treatment with Victoza in combination with a sulfonylurea or insulin, blood glucose self-monitoring may become necessary to adjust the dose of the sulfonylurea or the insulin.

Special populations

• Elderly patients (>65 years old): No dose adjustment is required based on age.
• Renal impairment: No dose adjustment is required for patients with mid, 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.
• 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.
• Paediatric population: The safety and efficacy of Victoza in children and adolescents below age 18 have not been established. 

Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of Liraglutide in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Liraglutide should not be used during pregnancy, and the use of insulin is recommended instead. If a patient wishes to become pregnant, or pregnancy occurs, treatment with Victoza should be discontinued.

Breast-feeding

It is not known whether Liraglutide is excreted in human milk. Animal studies have shown that the transfer of Liraglutide and metabolites of close structural relationship into milk is low. Non-clinical studies have shown a treatment-related reduction of neonatal growth in suckling rat pups . Because of lack of experience, Victoza should not be use during breast-feeding.

Fertility

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 during clinical trials were gastrointestinal disorders: nausea and diarrhoea were very common, whereas vomiting, constipation, abdomen pain, and dyspepsia were common. At the beginning of the therapy, these gastrointestinal adverse reactions may occur more frequently. These reactions usually diminish within a few days  or weeks of continued treatment.

Headache and nasopharyngitis were also common. Furthermore, hypoglycaemia was common, and very common when Liraglutide is used in combination with a sulfonylurea.Severe hypoglycaemia has primarily been observed when combined with a sulfonylurea. 

Common adverse effects

1. Nasppharyngitis.
2. Bronchitis.
3. Hypoglycaemia.
4. Anorexia.
5. Appetite decreased.
6. Headache.
7. Dizziness.
8. Increased heart rate.
9. Vomiting.
10. Dyspepsia.
11. Abdominal pain.
12. Constipation.
13. Gastritis.
14. Flatulence.
15. Abdominal distension.
16. Gastroesophageal reflux disease.
17. Abdominal discomfort.
18. Toothache.
19. Rash.
20. Fatigue.
21. Injection site reactions.
22. Increased lipase.
23. Increased amylase.

Instructions for using the VICTOZA PEN

For full instructions for using, Click this link to view PDF indicating how to use the pen.

Patient Information Leaflet

Victoza- Arabic information

Categories and tags: A10BJ02, Liraglutide, Glucagon-like peptide-1 (GLP-1) analogues, BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS, DRUGS USED IN DIABETES, ALIMENTARY TRACT AND METABOLISM.