User login
Enter your username and password here in order to log in on the website:
Please note: While some information will still be current in a year, other information may already be out of date in three months time. If you are in any doubt, please feel free to ask.
Cataract while taking Kaftrio/Trikafta®
- Question
- Hello,
Are there any experiences regarding cataracts in adolescents taking Kaftrio/Trikafta®?
Can lenses be replaced in cases of cystic fibrosis, and must the medication be discontinued if cataracts develop?
Thank you in advance for your reply.
Sincerely,
- Answer
- Dear Sir/Madam,
The finding that therapy with the modulator Kaftrio/Trikafta® (ivacaftor as the suspected substance) can trigger cataracts was initially based on animal studies in which rats were exposed to unphysiologically high doses, and the resulting cataracts were subsequently observed. Human data is based on the first pediatric ivacaftor study, in which the incidence of cataracts was 2.5%. There is also data from mothers who took Kaftrio, thus exposing their unborn children to Kaftrio during pregnancy and then again after birth during breastfeeding. In this setting, 3 cases of cataracts were reported (out of approximately 250).
The data currently available from reported adverse events in clinical practice show individual case reports of cataracts, but no specific percentages.
This has led to the recommendation that, when using Kaftrio in children (under 18 years of age), an ophthalmological examination should be performed before starting modulator therapy. This is because there are also congenital cataracts, which should be identified beforehand to determine whether they could be a potential side effect of Kaftrio. Subsequently, it is advisable to repeat the ophthalmological examination at regular intervals for children and adolescents, for example, once a year.
If a cataract is then diagnosed, there is no guideline stating that the therapy must be interrupted – this is at the discretion of the treating physicians and also depends on the findings: Is the opacity central to the lens and impairing vision? Or is it only at the periphery and poses no danger?
Generally, the procedure for CF patients who have a vision-impairing cataract, for whatever reason, is the same as for all patients: an artificial lens is implanted.
I hope this has been helpful.
Sincerely,
Daniela d'Alquen - 20.02.2026
