Semaglutide

Wegovy

Goedgekeurde toepassingen

• 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: Adults and pediatric patients aged 12 years and older with obesity; Adults with overweight in the presence of at least one weight-related comorbid condition.
• Coadministration with other semaglutide-containing products or with any other GLP-1 receptor agonist is not recommended.

Vormen en sterktes

• 2.4 mg/0.75 mL Injection: pre-filled, single-dose pen that delivers doses of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg.

Hoe het wordt ingenomen

• 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.
• 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. Important Monitoring and Administration Instructions

Mag niet worden gebruikt bij

• Personal or family history of MTC or in patients with MEN 2.
• Known hypersensitivity to semaglutide or any of the excipients in WEGOVY.

Interacties

• WEGOVY delays gastric emptying.
• May impact absorption of concomitantly administered oral medications.
• Use with caution.

Waarschuwingen en voorzorgen

• 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. Inform all patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia.
• Acute Kidney Injury: Has occurred. Monitor renal function when initiating or escalating doses of WEGOVY in patients reporting severe adverse gastrointestinal reactions or in those with renal impairment reporting severe adverse gastrointestinal reactions.
• Hypersensitivity Reactions: Anaphylactic reactions and angioedema have been reported postmarketing. Discontinue WEGOVY if suspected and promptly seek medical advice.
• Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: Has been reported in trials with semaglutide. Patients with a history of diabetic retinopathy should be monitored.
• Heart Rate Increase: Monitor heart rate at regular intervals.
• Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts. Discontinue WEGOVY if symptoms develop. Risk of Thyroid C-Cell Tumors In mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures.

Vaak voorkomende bijwerkingen

• Most common adverse reactions (incidence ≥ 5%) in adults or pediatric patients aged 12 years and older are: nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and nasopharyngitis.
• most common adverse reactions leading to discontinuation were nausea (1.8% versus 0.2%), vomiting (1.2% versus 0%), and diarrhea (0.7% versus 0.1%) for WEGOVY and placebo, respectively.

Zwangerschap

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. Risk Summary Based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy.

Werkingsmechanisme

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.

Handelsvergunninghouder:

A-S Medication Solutions

Versie van de productinformatie:

23 april 2024

De secties hierboven zijn geciteerd uit de Engelstalige productinformatie, want dat is het document dat de goedkeuring draagt. Waar een Europese instantie dezelfde informatie in het Nederlands publiceert, staat de link bij de bronnen. Wij vertalen regelgevende teksten niet zelf: een vertaalfout in een contra-indicatie is gevaarlijker dan een regel in een vreemde taal.

Deze sectie geeft de goedgekeurde productinformatie weer. De formulering is ingedikt uit de samenvatting van de toezichthouder zelf, en het volledige document staat bij de bronnen.