Dornase Alfa
Class: Mucolytic Agents
ATC Class: R05CB13
VA Class: RE900
Chemical Name: Deoxyribonuclease
CAS Number: 9003-98-9
Brands: Pulmozyme
Introduction
Mucolytic agent; biosynthetic (recombinant DNA origin) form of human deoxyribonuclease I (DNase I).
Uses for Dornase Alfa
Cystic Fibrosis
Adjunctive therapy in patients with cystic fibrosis to reduce mucus viscosity and enable the clearance of airway secretions to improve pulmonary function (designated an orphan drug by FDA for this use).
Reduces the frequency of respiratory infections requiring parenteral anti-infective therapy in patients with forced vital capacity (FVC) ≥40%.
Dornase Alfa Dosage and Administration
Administration
Oral Inhalation
Administer by oral inhalation via nebulization once daily.
Administer using a recommended nebulizer system; safety and efficacy of dornase alfa inhalation solution administered by a nebulizer system other than those listed below not established.
Use in patients unable to inhale or exhale orally throughout the entire nebulization period.
Nebulizer | Compressor |
|---|---|
Hudson T Up-draft II with | Pulmo-Aide |
Marquest Acorn II with | Pulmo-Aide |
PARI LC Jet+ with | PARI PRONEB |
PARI BABY with | PARI PRONEB |
Durable Sidestream with | Porta-Neb |
Durable Sidestream with | MOBILAIRE |
Oral inhalation solution should not be diluted nor mixed with any other drugs in the nebulizer.
Empty the entire contents of the single-use ampul of solution into the nebulizer cup; attach the cup to the inhalation apparatus according to the manufacturer’s instructions.
Place the mouthpiece of the nebulizer in the mouth and turn on the compressor. Breathe calmly and evenly through the mouth until the nebulizer stops producing a mist (duration of treatment for full dose is approximately 10–15 minutes).
Clean the nebulizer after use according to the manufacturer’s instructions.
Oral inhalation solution contains no preservatives; once the single-use ampul is opened, use the entire contents or discard the remainder.
Dosage
Each single-use ampul delivers 2.5 mg (2.5 mL of undiluted solution) to the nebulizer cup.
Pediatric Patients
Cystic Fibrosis
Oral Inhalation
Children ≥5 years of age: 2.5 mg once daily. Some patients (e.g., those with FVC >85%) may benefit from 2.5 mg twice daily.
Adults
Cystic Fibrosis
Oral Inhalation
2.5 mg once daily. Some patients (e.g., ≥21 years of age, those with FVC >85...
