AIFA Agenzia Italiana del Farmaco
Important Information Note on (crizotinib)
Vision disorders, which pose a known risk with crizotinib use, have been reported in clinical trials in 61% of paediatric patients with anaplastic large cell lymphoma (ALCL) positive for recurrent or refractory systemic anaplastic lymphoma (ANAF) kinase (ALCL) or with tumour Inflammatory Myofibroblastic Tumour (IMT) unresectable positive for ALK (anaplastic lymphoma kinase).
Because pediatric patients may not report or spontaneously notice vision changes, healthcare professionals should inform patients and caregivers of symptoms associated with vision disorders and the risk of vision loss, and advise them of the need to contact their physician if visual symptoms or vision loss develop.
Paediatric patients should be monitored for vision disorders.An ophthalmologic examination should be performed at baseline prior to initiation of treatment with crizotinib, with follow-up examinations within 1 month, every 3 months thereafter and if new visual symptoms are observed.
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Source — https://www.univadis.it/viewarticle/nota-informativa-importante-su-xalkori-crizotinib