Semaglutide

What it is and how it works

Mechanism of Action Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for native GLP-1. GLP-1 is a physiological regulator of appetite and caloric intake, and the GLP-1 receptor is present in several areas of the brain involved in appetite regulation. Animal studies show that semaglutide distributed to and activated neurons in brain regions involved in regulation of food intake. The exact mechanism of cardiovascular risk reduction has not been established.

Mechanism class: Glucagon-like Peptide-1 (GLP-1) Agonists

Indications

is indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight. • to reduce excess body weight and maintain weight reduction long term in: o Adults and pediatric patients aged 12 years and older with obesity o Adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use • WEGOVY contains semaglutide. Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended. WEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight .

Dosage and administration (summary)

• Administer WEGOVY once weekly as an adjunct to diet and increased physical activity, on the same day each week, at any time of day, with or without meals . • Inject subcutaneously in the abdomen, thigh or upper arm . • In patients with type 2 diabetes, monitor blood glucose prior to starting and during WEGOVY treatment . • Initiate at 0.25 mg once weekly for 4 weeks. Then follow the dosage escalation schedule, titrating every 4 weeks to achieve the maintenance dosage (2.2 , 2.3). • The maintenance dosage of WEGOVY in adults is either 2.4 mg (recommended) or 1.7 mg once weekly . • The maintenance dosage of WEGOVY in pediatric patients aged 12 years and older is 2.4 mg once weekly .

Contraindications

is contraindicated in the following conditions: • A personal or family history of MTC or in patients with MEN 2 . • A prior serious hypersensitivity reaction to semaglutide or to any of the excipients in WEGOVY. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with WEGOVY . • Personal or family history of MTC or in patients with MEN 2 . • Known hypersensitivity to semaglutide or any of the excipients in WEGOVY .

Warnings and precautions

• Acute Pancreatitis : Has occurred in clinical trials. Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed . • Acute Gallbladder Disease : Has occurred in clinical trials. If cholelithiasis is suspected, gallbladder studies and clinical follow-up are indicated . • Hypoglycemia: Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia. Reducing the dose of insulin or insulin secretagogue may be necessary.

Pregnancy

Pregnancy Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide during pregnancy. Pregnant women exposed to WEGOVY and healthcare providers are encouraged to contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com.

Storage and supply

Product: 50090-5824 NDC: 50090-5824-0 .5 mL in a SYRINGE, PLASTIC / 4 in a CARTON

Source: Semaglutide (Wegovy) — US FDA prescribing information, 2024-04-23, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.