Pulmozyme (Dornase Alfa) Dosing
The recommended dose of Pulmozyme is 2.5 mg (one single-dose ampule) inhaled once daily via nebulizer for all patients with cystic fibrosis aged 5 years and older. 1
Standard Dosing Regimen
- Adults and children ≥5 years: 2.5 mg inhaled once daily 1
- Some patients may benefit from twice daily administration (2.5 mg twice daily), particularly:
Pediatric Considerations
- Children 5-17 years: Use is supported by randomized controlled trial evidence demonstrating efficacy and safety 1
- Children <5 years (as young as 3 months): Use is supported by extrapolation of efficacy data from older children, with safety data from 65 pediatric patients aged 3 months to <5 years who received 2.5 mg daily for 2 weeks 1
- The same 2.5 mg once daily dose applies across all pediatric age groups 1
Administration Details
- Administer via compressed air-driven nebulizer or recommended nebulizer system 1
- Each ampule delivers 2.5 mL of solution containing 1 mg/mL dornase alfa 1
- The solution contains no preservative and should be used immediately after opening 1
Clinical Evidence Supporting Dosing
The 2.5 mg once daily dose demonstrated:
- 9.4% improvement in FEV1 compared to 2.1% for placebo (p<0.001) in patients with advanced lung disease 2
- 27% reduction in relative risk of respiratory tract infections requiring parenteral antibiotics 1
- Improved lung function and reduced exacerbations in patients with moderate to severe disease 3
The 2.5 mg twice daily dose showed:
- 29% reduction in relative risk of respiratory tract infections 1
- May be more beneficial in older patients (>21 years) and those with higher baseline lung function 1
Important Compatibility Warning
Do not mix Pulmozyme with Atrovent LS or Sultanol Inhalationslösung due to physicochemical incompatibility caused by benzalkonium chloride and disodium edetate excipients, which reduce dornase alfa activity 4. Pulmozyme can be mixed with preservative-free unit dose formulations of ipratropium or albuterol for a limited time 4.