Agenzia Italiana del Farmaco
Direct communication with healthcare professionals on Ozempic (semaglutide) e Victoza (liraglutide) - Direct communication with healthcare professionals on Ozempic (semaglutide) e Victoza (liraglutide)
Direct communication with healthcare professionals on Ozempic (semaglutide) e Victoza (liraglutide)
Novo Nordisk Spa in agreement with the European Medicines Agency and the Italian Medicines Agency (AIFA) would like to inform you of the following:
Summary
- Increased overall demand for Ozempam chic and Victoza injectable glucagon like peptide 1 receptor agonists (GLP 1 RAs) coupled with capacity constraints at some of our manufacturing sites have led to shortages, including out-of-stock situations. In addition, to facilitate increasing supply of Ozempic, Novo Nordisk decided to temporarily reduce the supply of Victoza. The shortage situation for Ozempic and Victoza will deteriorate in Q4 2023.
- For Ozempic, intermittent shortages are expected throughout 2024. For Victoza, shortages are expected at least until Q2 2024. The supply shortage is not related to a quality defect of the products or a safety issue.
- No new patients should be started on Victoza until at least Q2 2024 when supply is expected to normalise and available product should only be used to continue treatment of patients currently treated.
- Novo Nordisk will limit the supply of the starting dose for Ozempic (0.25 mg), which is expected to limit the initiation of new patients, to mitigate the increasing demand on the maintenance doses (Ozempic 0.5 mg and 1 mg). It is recommended to limit initiations of new patients during the shortage and until the supply situation improves which is expected in Q1 2024.
- In case Ozempic or Victoza is not available for patients currently treated with one of these respective products, patients should be safely switched to another injectable GLP 1 RA, or other suitable alternative based on your clinical judgement.
Published on: 13 November 2023