Risk Materials

Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.

Xospata Healthcare Professional (HCP) Educational Information Brochure

This HCP Educational Information Brochure aims to provide information about Differentiation Syndrome related to XOSPATA (gilteritinib), to minimise the risk associated with this safety concern. The brochure contains the following: -Information on Xospata, including the approved indication according to the SmPC. -Description of the signs and symptoms of differentiation syndrome. -Management of differentiation syndrome

For Healthcare Professionals

Xospata Patient Alert Card

Every Xospata 40 mg film-coated tablets pack contains a patient alert card. The purpose of the patient alert card is to provide: -Information for patients that Xospata treatment may cause differentiation syndrome. -Description of signs or symptoms of the safety concern and when to seek medical care if differentiation syndrome is suspected -A warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using Xospata. -Contact details of the treating physician who has prescribed Xospata. -Needs to be carried all the time and presented to any healthcare professional.

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