Cystic fibrosis

Active Ingredient: Dornase alfa

Indication for Dornase alfa

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Curative procedure

Management of cystic fibrosis patients with a forced vital capacity (FVC) of greater than 40% of predicted and over 5 years of age to improve pulmonary function.

For this indication, competent medicine agencies globally authorize below treatments:

2.5 mg once daily


Dosage regimens

Respiratory (Inhalation), 2.5 milligrams dornase alfa, once daily. The maximum allowed total dose is 5 milligrams dornase alfa daily.

Detailed description

2.5 mg (corresponding to 2500 U) deoxyribonuclease l by inhalation once daily.

Some patients over the age of 21 years may benefit from twice daily dosage.

Most patients gain optimal benefit from regular daily use of dornase alpha. In studies in which dornase alpha was given in an intermittent regimen, improvement in pulmonary function was lost on cessation of therapy. Patients should therefore be advised to take their medication every day without a break.

Patients should continue their regular medical care, including their standard regimen of chest physiotherapy.

Administration can be safely continued in patients who experience exacerbation of respiratory tract infection.

Safety and efficacy have not yet been established in patients with forced vital capacity less than 40% of predicted.

Active ingredient

Dornase alfa

Recombinant human DNase is a genetically engineered version of a naturally occurring human enzyme which cleaves extracellular DNA. In vitro, dornase alfa hydrolyses DNA in sputum and greatly reduces the viscoelasticity of cystic fibrosis sputum.

Read more about Dornase alfa

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