Finished product reference
Dornase Alfa (Desoxyribonuclease)
Solution · Respiratory · 1 mg/1mL · 2.5 mL
- List code
- 8081
- Pharmacologic class
- Recombinant Human Deoxyribonuclease 1
What it is and how it works
Mechanism of Action PULMOZYME is recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. In preclinical in vitro studies, PULMOZYME hydrolyzes the DNA in sputum of CF patients and reduces sputum viscoelasticity. In CF patients, retention of viscous purulent secretions in the airways contributes both to reduced pulmonary function and to exacerbations of infection. Purulent pulmonary secretions contain very high concentrations of extracellular DNA released by degenerating leukocytes that accumulate in response to infection.
Indications
® 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.
Dosage and administration (summary)
The recommended dosage is 2.5 mg (one single-dose ampule) inhaled once daily using a recommended nebulizer. Some patients may benefit from twice daily administration. See full prescribing information for the recommended nebulizers for use with PULMOZYME. Recommended Dosage The recommended dosage, in most cystic fibrosis patients, is 2.5 mg (one single-dose ampule) inhaled once daily using a recommended jet nebulizer connected to an air compressor system or via a vibrating mesh nebulizer . Some patients may benefit from twice daily administration .
Contraindications
is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product. PULMOZYME is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.
Warnings and precautions
None. None.
Pregnancy
Pregnancy Risk Summary There are no adequate and well-controlled studies with PULMOZYME in pregnant women. However, animal reproduction studies have been conducted with dornase alfa.
Storage and supply
Storage and Handling Store PULMOZYME ampules at a refrigerated temperature between 2°C to 8°C (36°F to 46°F) in their protective foil to protect from light and heat. Once the protective foil pouch is opened, the unused ampules must be kept refrigerated in the protective foil pouch to protect from light and heat.
Source: Dornase Alfa (Pulmozyme) — US FDA prescribing information, 2025-12-17, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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