dornase alfa
Drug Details
- Generic Name
- dornase alfa
- Brand Names
- Pulmozyme
- Application Number
- BLA103532
- Sponsor
- Lonza Biologics Tuas Pte Ltd.
- NDC Codes
- 3
- Dosage Forms
- LIQUID, SOLUTION
- Routes
- RESPIRATORY (INHALATION)
- Active Ingredients
- DORNASE ALFA
Indications and Usage
1 INDICATIONS AND USAGE PULMOZYME ® is indicated, in conjunction with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) to improve pulmonary function. In CF patients with an FVC ≥ 40% of predicted, daily administration of PULMOZYME has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics. PULMOZYME is a recombinant DNase enzyme indicated in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function. ( 1 )