Italian Medicines Agency Agenzia Italiana del Farmaco

Direct communication with healthcare professionals on Caprelsa® (vandetanib®) - Direct communication with healthcare professionals on Caprelsa® (vandetanib®)

Asset Publisher

Asset Publisher

Direct communication with healthcare professionals on Caprelsa® (vandetanib®)

Shortage of Caprelsa® (vandetanib®) 100 mg and 300 mg film-coated tablets.

Summary

  • In <INSERT COUNTRY>, a temporary shortage of Caprelsa® (vandetanib) 100 mg and 300 mg film-coated tablets is expected to begin / started on <INSERT DATE AND MONTH AS PER INDIVIDUAL COUNTRY>. [Each country to adapt according to specific supply situation] The shortage is expected to last until Q4 2022.
  • The shortage is due to an unexpected change of supplier of the active ingredient, as well as an increase in the demand globally. 
  • There is no additional risks for patients with Caprelsa® batches currently on the market, which can continue to be used. 
  • If Caprelsa® is not available, healthcare professionals are encouraged to consider treatment alternatives. 
  • Caprelsa®️ 100 mg film-coated tablets should not be used during this shortage period for patients treated with Caprelsa 300mg per day. Caprelsa 100 mg film-coated tablets should be reserved for pediatric patients and patients with renal failure or QT prolongation. As Caprelsa 300 mg film-coated tablets cannot be broken, every effort should be made to save Caprelsa®️ 100 mg film-coated tablets for these patients. 
  • In case of a shortage of 300 mg film-coated tablets or if 300 mg film-coated tablets are not marketed in your country, please reach out to Sanofi in your country to assess the possibility to provide 300 mg film-coated tablets from another country. The importation of Caprelsa 100mg film-coated tablets may also be possible on a case-by-case basis.


Published on: 29 July 2022

Asset Publisher

Asset Publisher

Galleria

Cookie Bar

cookie management module

Descrizione cookieBar

Questo sito utilizza cookie tecnici e analytics, necessari al suo funzionamento, per i quali non è richiesto il consenso. Per alcuni servizi aggiuntivi, le terze parti fornitrici, dettagliatamente sotto individuate, possono utilizzare cookies tecnici, analytics e di profilazione. Per saperne di più consulta la PRIVACY POLICY. Per proseguire nella navigazione devi effettuare la scelta sui cookie di terze parti dei quali eventualmente accetti l’utilizzo. Chiudendo il banner attraverso la X in alto a destra rifiuti tutti i cookie di terze parti. Puoi rivedere e modificare le tue scelte in qualsiasi momento attraverso il link "Gestione cookie" presente nel footer.

Social networks
go to beginning of content