Pulmozyme (Dornase Alfa) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

Drug Interactions

Clinical trials have indicated that Pulmozyme can be effectively and safely used in conjunction with standard cystic fibrosis therapies including oral, inhaled and/or parenteral antibiotics, bronchodilators, enzyme supplements, vitamins, oral or inhaled corticosteroids, and analgesics. No formal drug interaction studies have been performed.

OVERDOSAGE

Single-dose inhalation studies in rats and monkeys at doses up to 180-times higher than doses routinely used in clinical studies are well tolerated. Single dose oral administration of Pulmozyme in doses up to 200 mg/kg are also well tolerated by rats.

Cystic fibrosis patients have received up to 20 mg BID for up to 6 days and 10 mg BID intermittently (2 weeks on/2 weeks off drug) for 168 days. These doses were well tolerated.

CONTRAINDICATIONS

Pulmozyme is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.

REFERENCES

1. Shak S, Capon DJ, Hellmiss R, Marsters SA, Baker CL. Recombinant human DNase I reduces the viscosity of cystic fibrosis sputum. Proc Natl Acad Sci USA 1990;87:9188—92.
2. Boat TF. Cystic Fibrosis. In: Murray JF, Nadel JA, editors. Textbook of respiratory medicine. Philadelphia: Saunders WB, 1988;1:1126—52.
3. Collins FS. Cystic Fibrosis: molecular biology and therapeutic implications. Science 1992;256:774—9.
4. Potter JL, Spector S, Matthews LW, Lemm J. Studies of pulmonary secretions. Am Rev Respir Dis 1969;99:909—15.
5. Hubbard RC, McElvaney NG, Birrer P, Shak S, Robinson WW, Jolley C, et al. A preliminary study of aerosolized recombinant human deoxyribonuclease I in the treatment of cystic fibrosis. N Engl J Med 1992;326:812—5.
6. Aitken ML, Burke W, McDonald G, Shak S, Montgomery AB, Smith A. Recombinant human DNase inhalation in normal subjects and patients with cystic fibrosis. JAMA 1992;267(14):1947—51.
7. Fuchs HJ, Borowitz DS, Christiansen DH, Morris EM, Nash ML, Ramsey BW, 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;331:637—42.
8. McCoy K, Hamilton S, Johnson C. Effects of 12-week administration of dornase alfa in patients with advanced cystic fibrosis lung disease. Chest 1996;110:889—95.

Pulmozyme^®
(dornase alfa)
Inhalation Solution

Manufactured by
Genentech, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990

LE0339
7061805
(4824302)

Code Revision Date: October 2010
FDA Approval Date: January 2001
©2010 Genentech, Inc.
Pulmozyme^® is a trademark of Genentech, Inc.