Dosing and uses of Pulmozyme (dornase alfa)
Adult dosage forms and strengths
solution, inhalation
- 1mg/mL (2.5mL)
Cystic Fibrosis
2.5 mg nebulizer qDay or twice daily if needed
Pediatric dosage forms and strengths
solution, inhalation
- 1mg/mL (2.5mL)
Cystic Fibrosis
2.5 mg nebulizer qDay or twice daily if needed
Pulmozyme (dornase alfa) adverse (side) effects
>10%
Chest pain (18-25%)
Pharyngitis (32-40%)
Rash (3-12%)
Voice alteration (12-18%)
Rhinitis (30% in patients with FVC <40%)
Fever (32% in patients with FVC <40%)
1-10%
Dyspepsia (3%)
Conjunctivitis (1-5%)
Dornase alfa serum antibodies (2-4%)
Laryngitis (3-4%)
<1%
Headache
Urticaria
Warnings
Contraindications
Hypersensitivity to dornase alfa or Chinese hamster ovary cell products
Cautions
Use in conjunction with standard CF therapies
Dornase alfa therapy does not reduce the risk of respiratory infections that require parenteral antibiotics in patient with pulmonary function <40% of normaL
Experience with therapy in children < 5 years is limited
Safety and efficacy not established for therapy lasting > 12 months
Pregnancy and lactation
Pregnancy category: B
Lactation: Not known whether secreted in milk, use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Pulmozyme (dornase alfa)
Mechanism of action
Recombinant human DNase 1, digests neutrophil DNA deposited in the pulmonary mucosa thereby reducing mucosal viscoelasticity
Pharmacokinetics
Onset of action: Enzyme activity measured in sputum in 15 min
Duration: Activity declines rapidly
