European Union updates information for Kaftrio

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The European Medicines Agency has requested a change to the information included with Kaftrio.

The European Medicines Agency, the regulator for medicines in the European Union, has requested a change to the information (the label) included with Kaftrio®. This modulator treatment 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. The Trust has contacted the UK’s medicines regulator, the MHRA, for an update and we will share more information when we receive it.

The European label of Kaftrio has been updated to reflect impacts on mental health some people with cystic fibrosis have reported since taking the medication. If you have any concerns, please do speak to your CF team. You can also report side effects via the Yellow Card Scheme, but always discuss with your team before changing or stopping any treatment or medications.

Our Kaftrio factsheet, provides more information or you can call our Helpline on 0300 373 1000 or 020 3795 2184, Monday–Friday 10am–4pm, or email [email protected]

Dr Keith Brownlee, Medical Director at Cystic Fibrosis Trust

Kaftrio is a highly effective medicine for people suffering from cystic fibrosis, which addresses both the symptoms and the underlying causes of this condition.

As with all approved medicines, we continually monitor the safety of Kaftrio. We are currently reviewing all the available evidence on the potential risk of mental health disorders, including depression, that some patients have associated with this medicine.

We are working collaboratively with relevant patient charities and will seek advice from expert advisory groups of the Commission on Human Medicines. We will communicate any further advice to patients and healthcare professionals as appropriate.

If you or someone under your care is experiencing mental health issues while taking Kaftrio, please seek immediate assistance from your cystic fibrosis care team or healthcare professional. Do not change or stop your treatment without talking to them. We ask you to report any suspected side effects to our Yellow Card scheme.”

Dr Alison Cave, MHRA Chief Safety Officer

Read our Kaftrio factsheet here

Cystic Fibrosis Trust is funding research such as the RECOVER study to better understand the effects of Kaftrio and improve cystic fibrosis care and treatment.  Find out more here.

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