Italian Medicines Agency Agenzia Italiana del Farmaco

Direct communication with healthcare professionals on Ozempic® (semaglutide) - Direct communication with healthcare professionals on Ozempic® (semaglutide)

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Direct communication with healthcare professionals on Ozempic® (semaglutide)

Ozempic®(semaglutide) solution for injection in pre-filled pen: supply shortage.

Summary:

  • Increased demand for Ozempic® has led to shortages which are expected to continue throughout 2023. While supply will continue to increase, it is uncertain when it will be sufficient to meet full demand.
  • Delayed awareness of the out-of-stock situation may result in patients missing the required doses, which may have clinical consequences such as hyperglycaemia.
  • You are urged to ensure that patients using Ozempic® are made aware of this issue and that patients at risk of running out of Ozempic® are safely switched to another glucagon-like peptide-1 receptor agonist or other suitable alternatives based on your clinical judgement.
  • Ozempic is only indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as further detailed in the ‘Background section’ of this document. Any other use, including for weight management, is considered off-label and currently places the availability of Ozempic® for the indicated population at risk.


Published on: 06 March 2023

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