Pulmozyme is a type of bioengineered recombinant enzyme preparation that precisely targets free DNA molecules in sputum and specifically hydrolyzes the extracellular DNA network released by inflammatory cells, significantly reducing mucus viscoelasticity.

1、 Drug name and main ingredients

1. Common name: Dornasealfa Deoxyribonuclease

2. Product Name: PULMOZYME ®

3. Dosage form: Inhalation solution (single dose ampoule)

4. Main ingredients: Each 2.5mL ampoule contains 2.5mg Dornasealfa (1mg/mL), and the excipients are calcium chloride dihydrate (0.15mg/mL) and sodium chloride (8.77mg/mL).

2、 Indications

Cystic fibrosis (CF): Used in combination with standard therapy for adult and pediatric CF patients to improve lung function and reduce the risk of respiratory infections requiring intravenous antibiotics (baseline FVC ≥ 40% predictive value).

3、 Specifications and characteristics

1. Specification: 2.5mg/2.5mL (1mg/mL), 30 vials per box (5 foil bags x 6 ampoules).

2. Appearance: Colorless and transparent solution, ampoule designed for single dose, needs to be refrigerated and stored away from light.

4、 Usage and dosage

1. Recommended dose: 2.5mg (1 ampoule) once daily, inhaled through the recommended nebulizer; Some patients can increase it to twice a day.

2. Nebulizer selection: Specific spray atomizers (such as Hudson TUp draft II) need to be used ®) Or vibrating screen atomizer (such as eRapid) ® The system should not be diluted or mixed with other drugs.

3. Omission treatment: If it exceeds 12 hours, skip it and take it normally the next day; No need to take additional medication after vomiting.

5、 Dose adjustment

1. Renal insufficiency: Severe kidney injury (eGFR15-29mL/min) requires a reduction to 100mg once daily.

2. Combination use of strong CYP3A inhibitors: reduce dosage by 50mg.

6、 Medication precautions

1. High blood glucose monitoring: Regularly monitor fasting blood glucose and HbA1c before and during treatment.

2. Nebulizer usage: Before each use, check whether the ampoule leaks or the solution is turbid, and do not mix other drugs.

3. Storage requirements: Unopened ampoules should be refrigerated at 2-8 ° C. After opening, they should be placed back in foil bags for refrigeration. They should not be used if exposed to room temperature for more than 60 hours.

7、 Medication for special populations

1. Pregnant women: Animal experiments have not shown fetal risk, but human data is insufficient, use with caution.

2. Breastfeeding period: The content in breast milk is extremely low (<0.1% maternal blood drug concentration), and it should be used after weighing the pros and cons.

3. Children: Patients aged ≥ 5 years are safe and effective, while those aged<5 years require individualized assessment.

8、 Adverse reactions

1. Common (≥ 3%): voice changes (12-16%), pharyngitis (32-40%), rash (10-12%), chest pain (18-25%).

2. Serious reactions: pneumonia (14%), neutropenia (16%).

9、 Contraindications

Do not use for individuals allergic to Dornasealfa, CHO cell products, or any excipients.

10、 Drug interactions

1. Strong CYP3A inducers (such as rifampicin): avoid combination use;

2. BCRP inhibitors: may increase exposure to aprepitis.

11、 Storage method

1. Unopened: Refrigerate at 2-8 ° C and store in the original foil bag away from light;

2. Transportation: Keep refrigerated to avoid temperatures exceeding 28 ° C for more than 60 hours.

Pulmozymeinformation