Victoza^® (liraglutide) injection 1.2 mg or 1.8 mg is indicated as an adjunct to diet and exercise to improve glycemic control in patients 10 years and older with type 2 diabetes mellitus and 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^® should not be used in patients with type 1 diabetes mellitus or diabetic ketoacidosis.
• Concurrent use with prandial insulin has not been studied.

• Victoza^® is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with a prior serious hypersensitivity reaction to Victoza^® or to any of the product components. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with Victoza^®.

• Risk of Thyroid C-cell Tumors: Patients should be referred to an endocrinologist for further evaluation if serum calcitonin is measured and found to be elevated or thyroid nodules are noted on physical examination or neck imaging.
• Pancreatitis: Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza^® postmarketing. Observe patients carefully for signs and symptoms of pancreatitis (persistent severe abdominal pain, sometimes radiating to the back with or without vomiting). If pancreatitis is suspected, discontinue Victoza^® promptly and if pancreatitis is confirmed, do not restart. Victoza^® has been studied in a limited number of patients with a history of pancreatitis. It is unknown if patients with a history of pancreatitis are at a higher risk for development of pancreatitis on Victoza^®.
• Never Share a Victoza^® Pen Between Patients, even if the needle is changed. Pen-sharing poses a risk for transmission of blood-borne pathogens.
• Hypoglycemia: When Victoza^® is used with an insulin secretagogue (eg, a sulfonylurea) or insulin, serious hypoglycemia can occur. In pediatric patients 10 years of age and older, the risk of hypoglycemia was higher with Victoza^® regardless of concomitant antidiabetic therapies.
• Renal Impairment: Acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis, have been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration. Use caution when initiating or escalating doses of Victoza^® in patients with renal impairment.
• Hypersensitivity Reactions: Serious hypersensitivity reactions (eg, anaphylaxis and angioedema) have been reported post-marketing. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza^®; treat promptly per standard of care, and monitor until signs and symptoms resolve. Do not use in patients with a previous hypersensitivity reaction to Victoza^®. Anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-receptor agonist because it is unknown whether such patients will be predisposed to these reactions with Victoza^®.
• Acute Gallbladder Disease: In the LEADER trial, 3.1% of Victoza^® vs. 1.9% of placebo-treated patients reported an acute event of gallbladder disease, such as cholelithiasis or cholecystitis. The majority of events required hospitalization or cholecystectomy. If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow up are indicated.

• The most common adverse reactions, reported in ≥5% of patients treated with Victoza^® and more commonly than in patients treated with placebo, are nausea, diarrhea, headache, vomiting, decreased appetite, dyspepsia, and constipation. Immunogenicity-related events, including urticaria, were more common among Victoza^®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.

• Victoza^® causes a delay of gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Victoza^®.
• When initiating Victoza^®, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia.

• The safety and effectiveness of Victoza^® have not been established in pediatric patients less than 10 years of age.
• Victoza^® slows gastric emptying. Victoza^® has not been studied in patients with pre-existing gastroparesis.
• Victoza^® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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