RYBRILA (glycopyrronium bromide) - Severe sialorrhoea

First assessment.

Key points

Favourable opinion on the inclusion of RYBRILA (glycopyrronium bromide) in the “symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders".

Role in the care pathway?

RYBRILA (glycopyrronium bromide), an antimuscarinic anticholinergic agent, is the second medicinal product indicated in France in the treatment of severe sialorrhoea in children and adolescents aged 3 years and older after SIALANAR. The role of RYBRILA is similar to that of SIALANAR: it lies in second-line treatment after failure of a sufficiently long period of appropriate re-education in the treatment of severe sialorrhoea in children and adolescents aged 3 years and older. As there are limited long-term data, the duration of use must be short and intermittent. These two medicinal products must not be administered to children with mild-to-moderate sialorrhoea.

Changing from one product to the other without appropriate dosage adjustments may lead to an overdose and to anticholinerginic toxicity.