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Alfa deoxyribonuclease inhaler (Pulmozyme) is a bioengineered recombinant enzyme preparation that precisely targets free DNA molecules in sputum, specifically hydrolyzes the extracellular DNA network released by inflammatory cells, and significantly reduces the viscoelasticity of mucus.
1. Common name : Dornasealfa (Dornasealfa)
2. Trade name : PULMOZYME®
3. Dosage form :Inhalation solution (single-dose ampoule)
4. Main ingredients :Each 2.5mL ampoule contains 2.5mg Dornasalfa (1mg/mL), and the excipients are calcium chloride dihydrate (0.15mg/mL) and sodium chloride (8.77mg/mL).
Cystic fibrosis (CF) : Used in combination with standard therapies in adult and pediatric CF patients to improve lung function and reduce the risk of respiratory infections requiring intravenous antibiotics (when baseline FVC ≥ 40% predicted value).
1. Specifications : 2.5mg/2.5mL (1mg/mL), 30 pieces per box (5 foil bags × 6 ampoules).
2. Characteristics of : Colorless and transparent solution. The ampoule is designed for single dose and needs to be kept refrigerated and protected from light.
1. Recommended dose of : 2.5 mg (1 ampoule) once a day, inhaled through the recommended nebulizer; some patients can increase it to 2 times a day.
2. Nebulizer selection : It is necessary to use a specific jet nebulizer (such as Hudson TUp-draftII®) or vibrating screen nebulizer (such as eRapid® system), and other drugs cannot be diluted or mixed.
3. Treatment of missed doses : Skip if more than 12 hours, take it normally the next day; no need to take another dose after vomiting.
1. Renal insufficiency : Severe renal impairment (eGFR15-29mL/min) requires a dose reduction to 100mg once a day.
2. Combined use of strong CYP3A inhibitor : Reduce the dose by 50mg.
1. Hyperglycemia monitoring : Test fasting blood glucose and HbA1c regularly before and during treatment.
2. When using atomizer: Before each use, check whether the ampoule is leaking or the solution is turbid. Do not mix other drugs.
3. Storage requirements : Unopened ampoules need to be refrigerated at 2-8°C. After opening, they need to be returned to the foil bag and refrigerated. It is forbidden to expose them to room temperature for more than 60 hours.
1. Pregnant women : Animal experiments have not shown fetal risks, but human data are insufficient, so use with caution.
2. U200c during lactation: The content in breast milk is extremely low (<0.1% maternal plasma concentration), so use it after weighing the pros and cons.
3. Children : It is safe and effective for patients ≥5 years old, but requires individualized evaluation for patients <5 years old.
1. Common (≥3%) : Voice change (12-16%), pharyngitis (32-40%), rash (10-12%), chest pain (18-25%).
2. Severe reactions : Pneumonia (14%), neutropenia (16%).
It is prohibited for those allergic to Dornasalfa, CHO cell products or any excipients.
1. Strong CYP3A inducer (such as rifampicin) : Avoid combined use;
2. BCRP inhibitor : may increase apelix exposure.
1. Unopened : Refrigerate at 2-8°C and store in the original foil bag away from light;
2. Transportation : Need to keep refrigerated and avoid temperatures >28°C for more than 60 hours in total.