MHRA Drug Safety Update

07 May 2025

Kaftrio▼ (Ivacaftor, tezacaftor, elexacaftor): risk of psychological side effects

Psychological side effects such as anxiety, low mood, sleep disturbance, poor concentration, and forgetfulness have been infrequently reported in people with cystic fibrosis treated with Kaftrio. Healthcare professionals should advise patients and their caregivers that, while the risk is small, they should be alert to changes in mood and behaviour and, if they occur, to seek medical advice as soon as possible.

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