Brinsupri

Posology The recommended dose is 25 mg orally once daily with or without food. Missed dose Patients who miss a dose should take the next dose at their regular time the next day. Patients should not double the dose to make up for the missed dose.

2). 2). Paediatric population The safety and efficacy of Brinsupri in children younger than 12 years of age have not yet been established. No data are available. Method of administration For oral use. 3 This medicinal product should be taken once daily with or without food.

0%). Tabulated list of adverse reactions The safety of brensocatib was evaluated on the pooled safety population from two placebo-controlled clinical trials, ASPEN and WILLOW, which consisted of 1 326 adult and 41 adolescent patients 12 years of age and older with NCFB who received at least one dose of brensocatib for up to 52 weeks.

The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1:

Adverse reactions System organ class Frequency Adverse reaction Infections and infestations Common Upper respiratory tract infection Gastroenteritis Nervous system disorders Common Headache Gastrointestinal disorders Common Gingival disorder Periodontal disease Skin and subcutaneous tissue disorders Common Hyperkeratosis* Rash Dry skin Dermatitis Skin exfoliation Alopecia * See ‘Description of selected adverse reactions’ below.

1%). All events were of mild or moderate severity. 1). The safety profile in these adolescents was similar to that observed in adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

1%). Immunocompromised patients The safety of brensocatib has not been established in immunocompromised patients. Caution is advised when using brensocatib in patients with moderate to severe neutropenia (absolute neutrophil count [ANC] < 1,000/mm³).

Vaccinations The concomitant use of brensocatib and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving brensocatib. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1.