Agenzia Italiana del Farmaco
Direct communication with healthcare professionals on Caprelsa® (vandetanib®) - Direct communication with healthcare professionals on Caprelsa® (vandetanib®)
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
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