Xalkori® (crizotinib): Inclusion of a new warning regarding cardiac failure

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Date: 30 March 2016

 

Description:

The package inserts of Xalkori® will be updated with safety information on the risk of cardiac failure following a safety review of clinical trial data and post-marketing reports. There have been reports of cardiac failure, in some cases fatal, in those receiving crizotinib, involving patients with or without pre-existing cardiac disorders. Patients treated with crizotinib should be monitored for signs and symptoms of cardiac failure, and measures such as dosing interruption, reduction or discontinuation should be considered if such symptoms are identified. For further details, please refer to the Direct Healthcare Professional Communication (DHPC) issued by Pfizer (Malaysia) Sdn. Bhd., in agreement with NPCB.

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