MHRA Drug Safety Update: Kaftrio▼ (Ivacaftor, tezacaftor, elexacaftor) risk of psychological side effects

• there is a small increase in the risk of psychological side effects in people with cystic fibrosis treated with Kaftrio
• there is also an indirect risk of psychological side effects from difficulty adjusting to Kaftrio-related improvements to physical health and quality of life
• individuals with life-limiting conditions such as cystic fibrosis also have an increased background risk of developing poor mental health
• advise patients and their caregivers to be alert to the development of psychological side effects usually within the first three months of treatment including anxiety or low mood, sleep disturbance, poor concentration, or forgetfulness. The side effects may occur in people who have no history of these problems
• in some children, the psychological side effects may manifest themselves as persistent changes in behaviour while taking Kaftrio. Signs of this could include being more disruptive or difficult to manage
• discuss the benefit-risk balance of Kaftrio treatment with the patient or caregiver and consider treatment discontinuation if a patient develops these symptoms
• report suspected adverse drug reactions associated with Kaftrio on a Yellow Card

Advice for Healthcare Professionals to Provide to Patients:

• Kaftrio is a medicine used for the treatment of cystic fibrosis
• there have been infrequent reports in patients of all ages of low or altered mood, anxiety, problems with sleep, concentration, and/or forgetfulness
• some children, while taking Kaftrio, may notice persistent changes in the way they feel and/or act that are different to their usual patterns. This includes being more disruptive or difficult to manage
• these events usually happen within the first three months after starting treatment with Kaftrio and may occur in people who have no history of these problems
• it can be difficult for patients to know if their symptoms relate to Kaftrio or to something else. For some people, these changes can be associated with adjusting to the improvements that Kaftrio has on their physical health and their quality of life
• for many, the symptoms may not last long, but others will continue to experience them whilst they take Kaftrio
• you may not notice some changes in your mood and behaviour so it is very important to tell your friends and family that you are taking this medicine and that it can have psychological side effects. Others may notice changes and help you quickly identify any symptoms that you need to talk to your doctor about
• talk to your doctor or cystic fibrosis team as soon as possible if you or your family or friends notice signs or symptoms of psychological side effects. Your doctor will advise on the most appropriate action to take
• report suspected adverse drug reactions associated with Kaftrio on a Yellow Card

For further details, please view the full Drug Safety Update here.