"The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Pulmozyme (dornase alfa) should be used in conjunction with standard therapies for CF.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis: Lifetime studies in Sprague Dawley rats showed no carcinogenic effect when Pulmozyme (dornase alfa) was administered at doses up to 246 μg/kg body weight per day. Pulmozyme (dornase alfa) was administered to rats as an aerosol for up to 30 minutes per day, daily for two years, with resulting lower respiratory tract doses of up to 246 μg/kg per day, which represents up to a 28.8-fold multiple of the clinical dose. There was no increase in the development of benign or malignant neoplasms and no occurrence of unusual tumor types in rats after lifetime exposure.
Mutagenesis: Ames tests using six different tester strains of bacteria (4 of S. typhimurium and 2 of E. coli) at concentrations up to 5000 μg/plate, a cytogenetic assay using human peripheral blood lymphocytes at concentrations up to 2000 μg/plate, and a mouse lymphoma assay at concentrations up to 1000 mg/plate, with and without metabolic activation, revealed no evidence of mutagenesis potential. Pulmozyme (dornase alfa) was tested in a micronucleus (in vivo) assay for its potential to produce chromosome damage in bone marrow cells of mice following a bolus intravenous dose of 10 mg/kg on two consecutive days. No evidence of chromosomal damage was noted.
Impairment of Fertility: In studies with rats receiving up to 10 mg/kg/day, a dose representing systemic exposures greater than 600 times that expected following the recommended human dose, fertility and reproductive performance of both males and females was not affected.
Pregnancy (Category B)
Reproduction studies have been performed in rats and rabbits with intravenous doses up to 10 mg/kg/day, representing systemic exposures greater than 600 times that expected following the recommended human dose. These studies have revealed no evidence of impaired fertility, harm to the fetus, or effects on development due to Pulmozyme (dornase alfa) . There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed.
It is not known whether Pulmozyme is excreted in human milk. Small amounts of dornase alfa were detected in maternal milk of cynomolgus monkeys when administered a bolus dose (100 μg/kg) of dornase alfa followed by a six hour intravenous infusion (80 μg/kg/hr). Little or no measurable dornase alfa would be expected in human milk after chronic aerosol administration of recommended doses. Because many drugs are excreted in human milk, caution should still be exercised when Pulmozyme (dornase alfa) is administered to a nursing woman.
Because of the limited experience with the administration of Pulmozyme (dornase alfa) to patients younger than 5 years of age, its use should be considered only for those patients in whom there is a potential for benefit in pulmonary function or in risk of respiratory tract infection.
Cystic fibrosis is primarily a disease of pediatrics and young adults. Clinical studies of Pulmozyme (dornase alfa) did not include sufficient numbers of subjects aged 65 or older to determine whether they respond differently from younger subjects.
Last reviewed on RxList: 12/16/2008
This monograph has been modified to include the generic and brand name in many instances.
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