dornase alfa (Rx)

>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

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 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.

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