Italian Medicines Agency Agenzia Italiana del Farmaco

Direct communication with healthcare professionals on Xalkori (crizotinib) - Direct communication with healthcare professionals on Xalkori (crizotinib)

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Direct communication with healthcare professionals on Xalkori (crizotinib)

Vision disorders are a known risk with crizotinib and have been reported in 61% of paediatric patients with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) or recurrent, or refractory anaplastic lymphoma kinase (ALK)-positive unresectable inflammatory myofibroblastic tumour (IMT), in crizotinib clinical trials. 

As paediatric patients may not report or notice changes in vision spontaneously, healthcare professionals should inform patients and caregivers of the symptoms of vision disorders and the risk of visual loss, and to contact their healthcare provider if visual symptoms or visual loss develop.
Paediatric patients should be monitored for vision disorders. 

A baseline ophthalmologic examination should be undertaken prior to starting crizotinib, with follow-up examinations within 1 month, every 3 months thereafter, and upon observation of new visual symptoms.  


Published on: 04 November 2022

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