Liraglutide: Important Safety Information (ISI)

Read this information carefully before starting liraglutide. Discuss any questions with your provider.

What Is Liraglutide?

Liraglutide is a GLP-1 (glucagon-like peptide-1) receptor agonist used for chronic weight management and type 2 diabetes management. It is available under the brand names Saxenda® (FDA-approved for chronic weight management at the 3.0 mg dose) and Victoza® (FDA-approved for type 2 diabetes at doses up to 1.8 mg), both manufactured by Novo Nordisk.

Boxed Warning

WARNING: RISK OF THYROID C-CELL TUMORS. In rodent studies, liraglutide caused dose-dependent and treatment-duration-dependent thyroid C-cell tumors. It is unknown whether liraglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Liraglutide is contraindicated in patients with a personal or family history of MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the risk and symptoms of thyroid tumors (lump in neck, hoarseness, dysphagia, dyspnea).

Contraindications

• Personal or family history of medullary thyroid carcinoma (MTC)
• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Known serious hypersensitivity to liraglutide or any product components
• Pregnancy

Warnings and Precautions

• Pancreatitis: Acute pancreatitis (including hemorrhagic and necrotizing) reported. Discontinue if suspected. Use with caution in patients with history of pancreatitis.
• Hypoglycemia: Risk increases when used with insulin or insulin secretagogues (e.g., sulfonylureas). Dose reduction may be required.
• Acute Kidney Injury: Cases reported in association with severe dehydration from GI adverse reactions. Monitor renal function in patients with severe GI symptoms.
• Hypersensitivity: Serious hypersensitivity reactions including anaphylaxis and angioedema reported. Discontinue immediately if suspected.
• Gallbladder Disease: Cholelithiasis and cholecystitis reported. Evaluate patients with gallbladder symptoms.
• Suicidal Behavior and Ideation: Monitor for depression, suicidal thoughts, and unusual changes in behavior. Discontinue if symptoms develop.
• Heart Rate Increase: Mean increase in resting heart rate observed. Monitor periodically.

Most Common Adverse Reactions

Most common adverse reactions reported in clinical trials of liraglutide for chronic weight management:

• Nausea (39%)
• Diarrhea (21%)
• Constipation (19%)
• Vomiting (16%)
• Hypoglycemia (in T2D patients)
• Decreased appetite
• Headache
• Fatigue
• Dyspepsia
• Dizziness
• Injection site reactions

Drug Interactions

Liraglutide slows gastric emptying and may affect the absorption of concomitantly administered oral medications. Monitor patients on oral medications requiring consistent absorption. Increased risk of hypoglycemia when used with insulin or insulin secretagogues; dose reduction of insulin or sulfonylureas may be needed.

Use in Specific Populations

• Pregnancy: Liraglutide is contraindicated. Discontinue at least 2 months before a planned pregnancy. May cause fetal harm.
• Lactation: Unknown whether liraglutide is present in human milk. Consider risk and benefit when prescribing to nursing mothers.
• Pediatric Use: Saxenda® is approved for adolescents 12 years and older with body weight greater than 60 kg meeting BMI criteria.
• Renal Impairment: No dose adjustment for mild to moderate impairment. Limited experience in severe renal impairment or dialysis.
• Hepatic Impairment: Limited data; use with caution.