The Italian Medicines Agency (AIFA) is making available a Direct Healthcare Professional Communication (DHPC) for Litfulo (ritlecitinib) to inform healthcare professionals of updated recommendations for the use of this medicine.

Following a review of the latest safety data, the recommendations for the use of Litfulo have been updated to align them with those already in place for other Janus kinase (JAK) inhibitors, with the aim of minimising the risk of major adverse cardiovascular events (MACE), malignancies, serious infections and venous thromboembolism (VTE).

Therefore, Litfulo should only be used if no suitable treatment alternatives are available in patients aged 65 years or older, in patients with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (including current or long-term past smokers), and in patients with risk factors for malignancy.

In addition, Litfulo should be used with caution in patients with risk factors for venous thromboembolism (VTE), and all patients should undergo periodic skin examinations to monitor for the development of skin malignancies.

Further information is provided in the related document.

Healthcare professionals are reminded of the importance of reporting suspected adverse reactions to ensure continuous monitoring of drug safety and the protection of patient health.