Important change to the information leafet (the label) provided with Kaftrio®
The European Medicines Agency (EMA), the regulator for medicines in the European Union, has requested a change to the information included with Kaftrio®. This information is known as ‘the label’ and is the information leaflet that people with CF/parents will be familiar with and will find accompanying Kaftrio® and which has now been amended.
Kaftrio® has helped transform the lives of many people with cystic fibrosis by treating the underlying cause of the condition. However, although most people’s experiences have been positive, this has not been the case for everyone.
The changes requested reflect the psychological impacts reported by some people. In particular, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) considers that there is at least a reasonable possibility of a causal relationship between KAFTRIO® and depression.
Most people with CF and their families will likely be already aware of discussion and emerging evidence about this possible causal relationship, so the EMA decision is a prudent one and we would advise reading of the updated label.
As always, people with CF who are being prescribed Kaftrio® and have any concerns they should contact their CF team.