No

Enzyme

Management of cystic fibrosis patients to reduce the frequency of respiratory infections that require parenteral antibiotics, and to improve pulmonary function; has also demonstrated value in the treatment of chronic bronchitis

B

Contraindicated in patients with known hypersensitivity to dornase alfa, Chinese hamster ovary cell products (eg, epoetin alfa), or any component

No clinical trials have been conducted to demonstrate safety and effectiveness of dornase in children <5 years of age, in patients with pulmonary function <40% of normal, or in patients for longer treatment periods >12 months; no data exists regarding safety during lactation

>10%:

Respiratory: Pharyngitis

Miscellaneous: Voice alteration

1% to 10%:

Cardiovascular: Chest pain

Dermatologic: Rash

Ocular: Conjunctivitis

Respiratory: Laryngitis, cough, dyspnea, hemoptysis, rhinitis, hoarse throat, wheezing

Dornase alfa can be effectively and safely used in conjunction with standard CF therapies including oral, inhaled, and parenteral antibiotics, bronchodilators, enzyme supplements, vitamins, oral and inhaled corticosteroids, and analgesics. No formal drug interaction studies have been performed.

Must be stored in the refrigerator at 2°C to 8°C (36°F to 46°F) and protected from strong light; should not be exposed to room temperature for a total of 24 hours

The hallmark of cystic fibrosis lung disease is the presence of abundant, purulent airway secretions composed primarily of highly polymerized DNA. The principal source of this DNA is the nuclei of degenerating neutrophils, which is present in large concentrations in infected lung secretions. The presence of this DNA produces a viscous mucous that may contribute to the decreased mucociliary transport and persistent infections that are commonly seen in this population. Dornase alfa is a deoxyribonuclease (DNA) enzyme produced by recombinant gene technology. Dornase selectively cleaves DNA, thus reducing mucous viscosity and as a result, airflow in the lung is improved and the risk of bacterial infection may be decreased.

Following nebulization, enzyme levels are measurable in the sputum within 15 minutes and decline rapidly thereafter

Children >5 years and Adults: Inhalation: 2.5 mg once daily through selected nebulizers in conjunction with a Pulmo-Aide® or a Pari-Proneb® compressor

Nebulization: Should not be diluted or mixed with any other drugs in the nebulizer, this may inactivate the drug

None reported

None reported

No information available to require special precautions

No effects or complications reported

Use exactly as directed by prescriber (see Administration below). Report any signs of adverse response, skin rash, sore throat, respiratory wheezing, cough, or difficulty breathing. Breast-feeding precautions: Consult prescriber if breast-feeding.

Should not be diluted or mixed with any other drugs in the nebulizer, this may inactivate the drug

Solution, inhalation: 1 mg/mL (2.5 mL)

Albertson TE, Walby WF, Allen RP, et al, "The Pharmacology and Toxicology of Three New Biologic Agents Used in Pulmonary Medicine," J Toxicol Clin Toxicol, 1995, 33(5):427-38.

Fuchs HJ, Borowitz DS, Christiansen DH, et al, "Effect of Aerosolized Recombinant Human DNase on Exacerbations of Respiratory Symptoms and on Pulmonary Function in Patients With Cystic Fibrosis," N Engl J Med, 1994, 331(10):637-42.

Hubbard RC, McElvaney NG, Birrer P, et al, "A Preliminary Study of Aerosolized Recombinant Human Deoxyribonuclease I in the Treatment of Cystic Fibrosis," N Engl J Med, 1992, 326(12):812-5.

Mueller GA, Rubins G, Wessel D, et al, "Effects of Dornase Alfa on Pulmonary Function Tests in Infants with Cystic Fibrosis," Am J Respir Crit Care Med, 1996, 153:A70.

Rock M, Kirchner K, McCubbin M, et al, "Aerosol Delivery and Safety of rhDNASE in Young Children With Cystic Fibrosis: A Bronchoscopic Study," Pediatr Pulmonol, 1996, 13(Suppl):A268.