AIFA Agenzia Italiana del Farmaco
Important Information Note on Caprelsa (vandetanib)
Deficiency of Caprelsa (vandetanib) 100 mg and 300 mg film-coated tablets.
Summary:
There is currently a temporary shortage of Caprelsa (vandetanib) 100 mg and 300 mg film-coated tablets in Italy. The availability of the medicine is limited and at the moment its supply takes place in quota mode.This situation is expected to resolve at the beginning of the fourth quarter of 2022.
The shortage is due to an unexpected change of supplier of the active ingredient, as well as an increase in demand globally.
There are no additional risks for patients with batches of Caprelsa® currently on the market, which can continue to be used.
If Caprelsa is not available, healthcare professionals are encouraged to® consider treatment alternatives.
Caprelsa 100mg film-coated tablets should not be used during this deficiency period for patients treated with Caprelsa 300mg daily. Please note that Caprelsa 100 mg film-coated tablets should be reserved for paediatric patients or patients requiring a dose reduction of Caprelsa 300 mg due to renal impairment or QT prolongation. Please also note that Caprelsa 300 mg film-coated tablets are not divisible, therefore Caprelsa 100 mg should be reserved for patients requiring this dosage only.
To ensure the availability of the drug to patients requiring a dosage of 100 mg, healthcare professionals are advised to avoid providing 3 tablets of 100 mg to reach the dose of 300 mg for patients receiving the standard dosage.
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Source — https://www.univadis.it/viewarticle/nota-informativa-importante-su-caprelsa-vandetanib