Indicated for:

Type 2 Diabetes Mellitus:

• As an adjunct to diet and exercise to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus.

Reduce Risk of Major Adverse Cardiovascular Events:

• To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.

VICTOZA is not a substitute for insulin.

VICTOZA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

VICTOZA should not be used in patients with type 1 diabetes mellitus.

VICTOZA contains liraglutide and should not be co-administered with other liraglutide-containing products.

When initiating VICTOZA, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycemia.

Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether VICTOZA causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.

VICTOZA is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of VICTOZA and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with VICTOZA.

Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with VICTOZA. VICTOZA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using VICTOZA. Other antidiabetic therapies should be considered in patients with a history of pancreatitis.

Patients receiving VICTOZA in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin.

In pediatric patients 10 years of age and older, the risk of hypoglycemia was higher with VICTOZA regardless of concomitant antidiabetic therapies.

There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with VICTOZA.

Jaundice and hepatitis have been reported during post-marketing use of liraglutide.

There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in VICTOZA treated patients.

Reports of acute event of gallbladder disease, such as cholelithiasis or cholecystitis.

Based on animal reproduction studies, there may be risks to the fetus from exposure to VICTOZA during pregnancy.

It is not known whether VICTOZA is excreted in human milk. Liraglutide was present in milk of lactating rats.

GoToSource

• Use in patients under 10 years of age. GoToSource

• Type 1 diabetes mellitus, for diabetic ketoacidosis or as first-line therapy. GoToSource

• Weight loss. GoToSource

• Neurodegenerative disorders including alzheimer’s disease and parkinson’s disease. GoToSource

Pancreatitis (inflammation of pancreas). GoToSource

Increased risk of thyroid cancer. GoToSource

Increased risk of medullary thyroid cancer. GoToSource

Kidney failure. GoToSource 

Hypoglycemia (low blood sugar). GoToSource

Autoimmune hepatitis. GoToSource

Lawsuits filed for thyroid cancer, pancreatitis and kidney failure.