This educational material is intended to minimize several risks identified in the frame of the European risk management plan established for Leflunomide. The most important risks you should be aware of when prescribing Leflunomide include: • Risk of hepatotoxicity, including very rare cases of severe liver injury, which may be fatal. • Risk of hematotoxicity, including rare cases of pancytopenia, leucopenia, eosinophilia and very rare cases of agranulocytosis. • Risks of infections including rare cases of severe uncontrolled infections (sepsis), which may be fatal. • Risk of serious birth defects when administered during pregnancy. Counselling of patients, careful monitoring and following recommendations regarding the wash-out procedure are required to minimise these risks. Complete prescribing information is provided in the approved Summary of Product Characteristics (SmPC) for Leflunomide.