Additional risk reduction measures

So-called "routine" measures govern the proper use of the medicine: these are the information in the Summary of Product Characteristics for professionals and the package leaflet for patients, the packaging of the medicine or the introduction of prescription and dispensing conditions. When they appear insufficient to ensure safe and effective use, additional risk reduction measures (RRMs) may be implemented. MARRs are intended to prevent or reduce the likelihood of adverse reactions, their severity and/or impact on the patient.

XOSPATA™

As part of the Risk Management Plan for the Xospata specialty, and in agreement with the ANSM, Astellas provides the following additional risk reduction measures:

• Prescriber Guide
• Patient alert card: A patient alert card is available in every box of Xospata.

PADCEV™

As part of the Risk Management Plan for the Padcev specialty, and in agreement with the ANSM, Astellas provides the following additional risk reduction measure:

• Patient Information Kit: A leaflet and a patient card are available in each box of Padcev.