Victoza 6 mg Solution

Victoza ® is indicated as an adjunct to diet and exercise to achieve glycaemic control in patients with type 2 diabetes mellitus. Victoza ® is indicated for once-daily administration as:

• monotherapy
• combination therapy with one or more oral antidiabetic medicines (metformin, sulphonylureas, sodium-glucose cotransporter 2 inhibitor (SGLT2i) or a thiazolidinedione) when previous therapy does not provide adequate glycaemic control.
• combination therapy with insulin in patients not achieving adequate glycaemic control with Victoza ® and metformin.

Prevention of cardiovascular events: Victoza ® is indicated to prevent Major Adverse Cardiovascular Events (MACE: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus at high cardiovascular risk, as an adjunct to standard of care therapy (see section 5 Pharmacological Properties).

Contraindications

• Hypersensitivity to liraglutide or any of its excipients
• A history of previous pancreatitis
• Type 1 diabetes mellitus
• Pregnancy and lactation (see section 4.6 Pregnancy)

Special warnings and precautions for use

Victoza ® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Victoza ® should not be administered intravenously or intramuscularly. Victoza ® is not a substitute for insulin. Safety and efficacy of Victoza ® in patients below 18 years of age has not been established.

Patients above 70 years may experience more gastrointestinal effects when treated with Victoza ®. Patients with mild and moderate renal impairment (creatinine clearance 60 − 90 ml/min and 30 − 59 ml/min, respectively) may experience more gastrointestinal effects when treated with Victoza ®.

There is no therapeutic experience in patients with end-stage renal disease and Victoza ® is therefore not recommended for use in these patients. There is no therapeutic experience in patients with congestive heart failure New York Heart Association (NYHA) class IV and Victoza ® is therefore not recommended for use in these patients.

There is limited experience in patients with inflammatory bowel disease and diabetic gastroparesis and Victoza ® is therefore not recommended for use in these patients. The use of Victoza ® is associated with gastrointestinal adverse reactions, including nausea, vomiting and diarrhoea.

Hypoglycaemia

Patients receiving Victoza ® in combination with a sulphonylurea or insulin may have an increased risk of hypoglycaemia. The risk of hypoglycaemia can be lowered by a reduction in the dose of sulphonylurea or insulin.

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. Injection sites should always be rotated within the same region in order to reduce the risk of cutaneous amyloidosis (see section 4.8 Undesirable effects). The injection site and timing can be changed without dose adjustment.

The most frequently reported adverse events during clinical trials were gastrointestinal adverse events: nausea and diarrhoea (reported by > 10 % of patients) and vomiting, dyspepsia, upper abdominal pain, constipation, gastritis, flatulence, abdominal distension, gastro-oesophageal reflux disease and eructation (reported by ≥ 1 % and ≤ 10 % of patients). Headache and upper respiratory tract infections were common. Furthermore, hypoglycaemia was common and very common especially when Victoza ® is used in combination with sulphonylurea.

Severe hypoglycaemia may occur uncommonly and has only been observed when combined with a sulphonylurea.

Store in a refrigerator (2 °C – 8 °C). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze Victoza ® and do not use Victoza ® if it has been frozen. After first use of the Victoza ® pen, the product can be stored for 1 month at room temperature (not above 30 °C) or in a refrigerator at (2 °C – 8 °C). Victoza ® should be protected from excessive heat and sunlight. Always remove the injection needle after each injection and store the Victoza ® pen without an injection needle attached. This prevents contamination, infection and leakage. It also ensures that the dosing is accurate. Recap the pen to protect from light. Keep out of reach and sight of children.