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This FDA prescribing information outlines the indications, dosing, and safety profile (including gastrointestinal events, gallbladder disease, heart rate increases, and hypoglycemia) for subcutaneous liraglutide 3 mg daily in adults and pediatric patients with obesity or overweight.
1 • The safety and effectiveness of SAXENDA ® in pediatric patients with type 2 diabetes have not been established.(1) ---DOSAGE AND ADMINISTRATION ---• Inject SAXENDA ® subcutaneously in the abdomen, thigh, or upper arm once daily at any time of day, without regard to the timing of meals.(2.1) • The recommended dose of SAXENDA ® is 3 mg daily.(2.2) • Initiate at 0.6 mg per day for one week.In weekly intervals, increase the dose until a dose of 3 mg is reached.(2.2) • If pediatric patients do not tolerate an increased dose during dose escalation, the dose may also be lowered to the previous level.Dose escalation for pediatric patients may take up to 8 weeks.(2.2) • Pediatric patients who do not tolerate 3 mg daily may have their dose reduced to 2.4 mg daily.(2.2) • Adult patients with type 2 diabetes should monitor blood glucose prior to starting SAXENDA ® and during SAXENDA ® treatment.(2.2) ---DOSAGE FORMS AND STRENGTHS ---Injection: 6 mg/mL solution in a 3 mL prefilled, single-patient-use pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg.(3) ---CONTRAINDICATIONS ---• Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. (4) • Hypersensitivity to liraglutide or any excipients in SAXENDA ® .(4) ---WARNINGS AND PRECAUTIONS ---• Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including SAXENDA ® .Discontinue if pancreatitis is suspected.(5.2) • Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated.(5.3) • Hypoglycemia: Can occur in adults when SAXENDA ® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin.The risk may be lowered by a reduction in the dose of concomitantly administered insulin secretagogues or insulin.In the pediatric clinical trial, patients did not have type 2 diabetes.Hypoglycemia occurred in SAXENDA ® -treated pediatric patients.Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.(5.4) • Heart Rate Increase: Monitor heart rate at regular intervals.(5.5) 14.2 Weight Management Trial in Pediatric Patients Ages 12 and Older with Obesity 15
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Kacey Bartscher (2026) studied Overweight or obesity (n=5,325). Liraglutide (SAXENDA) vs. Placebo was evaluated on Time from randomization to first occurrence of a major adverse cardiovascular event (MACE: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in the LEADER cardiovascular safety trial.
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