INTENDED FOR UK & IRELAND HEALTHCARE PROFESSIONALS

INTENDED FOR UK & IRELAND HEALTHCARE PROFESSIONALS

PRESCRIBING INFORMATION

Bronchitol® (mannitol)
Key information
  • Bronchitol (mannitol) is indicated for the treatment of cystic fibrosis in adults as an add-on therapy to best standard of care1
  • Dry powder inhaler for use in adults aged 18 years and above1,2
  • Three Phase III studies (CF301,* CF302 and CF303) demonstrated statistical significance in absolute FEV1 change compared to control (p<0.001, p=0.038 and p=0.020 respectively) in the adult population at week 261
  • Adverse events were generally mild or moderate and consistent with cystic fibrosis and its standard treatment3^
  • The Bronchitol Initiation Dose Assessment (BIDA) must be undertaken for each patient before starting Bronchitol1
  • UK healthcare professionals should also refer to the Risk Minimisation Material and can download our UK Electronic BIDA Sheet

FEV1, forced expiratory volume in 1 second


*Multi-centre, randomised, double-blind, controlled study; 400mg Bronchitol®, twice daily, n=269 (overall population). Sub-group study analysis of adult population (n=171) shown here.
†Multi-centre, randomised, double-blind, controlled, parallel group study; 400mg Bronchitol® twice daily, n=297 (overall population). Sub-group study analysis of adult population (n=144) shown here.
‡Multi-centre, randomised, double-blind, controlled, parallel group study; 400 mg Bronchitol® twice daily, n=423 adult patients
^Pooled analysis of adult patients

1. Bronchitol® Summary of Product Characteristics. Available online at https://www.medicines.org.uk/emc/product/4085/smpc. Accessed December 2019.
2. Bronchitol Patient Information Leaflet.
3. Flume PA, et al. Breathe 2015; 11(1):39-48.