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Pulmozyme 1mg/mL (2.5mL ampule) Inhalation Solution
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Indications & Clinical Uses
- Pulmozyme (dornase alfa) 1 mg/mL is a genetically engineered (recombinant) enzyme supplied as an inhalation solution in single-dose ampoules for use in a nebulizer.
- It is indicated, together with standard cystic fibrosis therapies, to help thin and clear the thick mucus in the airways of people with cystic fibrosis, improving lung function; in patients with a forced vital capacity of 40% of predicted or higher it also reduces the risk of respiratory infections needing intravenous antibiotics.
- It works by breaking down extracellular DNA released from white blood cells in infected, inflamed mucus, which makes the secretions less viscous and easier to clear by coughing.
- It is used long-term as part of ongoing cystic fibrosis care, usually self-administered at home by the patient or a caregiver once daily through a jet nebulizer, and is not approved for other lung conditions such as COPD.
Side Effects
- The most common side effects of Pulmozyme reported in trials, occurring more often than with placebo, are voice changes (hoarseness), sore throat, laryngitis, chest pain, conjunctivitis (eye redness or irritation), rash and rhinitis (runny or stuffy nose).
- A temporary drop in lung function (forced vital capacity), fever and shortness of breath were also seen in some patients, usually settling without stopping treatment.
- Hypersensitivity reactions, including rash, hives, facial or throat swelling, and, rarely, more severe allergic reactions, can occur; stop treatment and seek medical advice if these develop.
- There is no boxed warning on the current label.
- Because Pulmozyme is made using Chinese Hamster Ovary cell technology, patients with known hypersensitivity to dornase alfa or CHO cell products should not use it.
Precautions & Warnings
- Pulmozyme is for inhalation only, using a recommended jet nebulizer and compressor system as specified in the label; it must not be diluted or mixed with other drugs or solutions in the nebulizer chamber, since this can affect both the structure of the drug and the performance of some nebulizers.
- It is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the formulation.
- There is no specific guidance restricting use in pregnancy or breastfeeding beyond standard clinical judgement, and it has not been shown to cause the systemic effects typical of oral or injected medicines, since it acts locally in the airway.
- Ampoules must be kept refrigerated at 2°C to 8°C in their protective foil pouch, protected from light and heat, and unopened ampoules exposed to room temperature for more than a total of 60 hours should not be used.
Avoid Interactions
- Available clinical data indicate no clinically important drug-drug interactions between Pulmozyme and other medicines commonly used in cystic fibrosis care, including antibiotics, bronchodilators and pancreatic enzyme supplements.
- As a locally acting inhaled enzyme with minimal systemic absorption, it is not expected to interact with orally or intravenously administered drugs metabolised through the liver.
- Do not mix Pulmozyme with any other drug or diluent in the nebulizer cup, because compatibility and stability have not been established and this may affect delivery or the enzyme's activity; use it alone in a nebulizer that is compatible with the label's specifications.
- Tell the healthcare provider or pharmacist about all other medicines and inhaled treatments being used so the overall respiratory treatment plan can be reviewed.
References
Frequently Asked Questions
Pulmozyme (dornase alfa) is an inhaled enzyme used alongside standard therapy to thin thick mucus in people with cystic fibrosis. It improves lung function and, in patients with better lung capacity, lowers the risk of infections needing IV antibiotics.
Pulmozyme is inhaled once daily through a jet nebulizer, usually self-administered or given by a caregiver at home. The full contents of one ampoule are used undiluted; do not mix it with other drugs in the nebulizer cup.
Common side effects include voice changes, sore throat, laryngitis, chest pain, eye irritation and rash. Some people have a temporary dip in lung function or a fever. Stop and seek advice if you notice facial swelling or hives.
Do not mix Pulmozyme with any other medicine or solution in the nebulizer, since this is not tested and may reduce how well it works. Avoid using it in a nebulizer not recommended in the label, and tell your provider about all other CF treatments you use.
Keep Pulmozyme ampoules refrigerated at 2°C to 8°C in their foil pouch, protected from light. If ampoules are out of the fridge, they must not exceed a total of 60 hours at room temperature (22°C to 28°C) before use.
Yes, Pulmozyme (dornase alfa) is used long-term as part of ongoing cystic fibrosis care and has no boxed warning. It acts locally in the airway with minimal absorption into the body, and treatment continues as long as it remains clinically beneficial.
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