WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?
Pulmozyme contains dornase alfa — a genetically engineered (recombinant)
version of a naturally occurring human enzyme called deoxyribonuclease (DNase
I). In cystic fibrosis (CF), the lungs produce an extremely thick, sticky mucus
that is very difficult to clear.
This mucus blocks the airways, traps bacteria, and leads to repeated lung
infections and progressive lung damage. A major component of this thick mucus
is extracellular DNA — released when white blood cells die fighting infections.
Dornase alfa breaks down this DNA, significantly reducing the viscosity
(thickness) of the mucus and making it much easier to cough up and clear. Daily
nebulisation of dornase alfa reduces the frequency of respiratory infections
(exacerbations) requiring antibiotics, improves lung function (FEV1), and helps
slow the progressive decline in lung function in CF. It is used in patients
with cystic fibrosis aged 5 years and older with an FVC (forced vital capacity)
of at least 40% of predicted.
3. HOW TO TAKE THIS MEDICINE
The standard dose is one ampoule (2.5mg / 2.5mL) inhaled once daily via a
suitable jet nebuliser. Some patients may benefit from twice-daily use under
specialist guidance. The medicine should ideally be used in the morning, before
airway clearance physiotherapy (chest physiotherapy/percussion) — the thinned
mucus is then more effectively cleared during physio. Pulmozyme must only be
used with a compatible jet nebuliser — not an ultrasonic nebuliser, as these
can damage the enzyme.
Pulmozyme must be used with a jet nebuliser that has been recommended by
your CF team. Ultrasonic nebulisers inactivate the enzyme and must not be used.
The ampoule contents should not be diluted. After nebulisation, rinse the mouth
and rinse the nebuliser with clean water and allow to air dry. Ampoules are
single use — discard any unused portion.
⚠ PATIENT TIP: Timing matters: use your
Pulmozyme before your daily chest physiotherapy if possible. The enzyme thins
the mucus over 30 to 60 minutes — doing your airway clearance exercises after
the nebuliser gives the thinned mucus the best chance of being cleared from
your lungs. This combined approach is much more effective than either treatment
alone.
4. POSSIBLE SIDE EFFECTS
|
How Common? |
Side Effects |
|
Common |
Hoarseness or voice
changes (laryngitis), sore throat, runny nose (rhinitis), pharyngitis (throat
irritation), rash, chest pain or discomfort, conjunctivitis (red eyes) |
|
Less Common |
Breathlessness, fever,
cough increase (temporary — usually means the mucus is being mobilised and
cleared, which is a positive sign) |
|
Rare |
Haemoptysis (coughing
up blood — report to CF team). Severe allergic reactions are rare but
possible — stop nebulisation and seek medical advice if you develop facial
swelling, severe rash, or breathing difficulty. |
5. WHO SHOULD NOT TAKE THIS MEDICINE
Pulmozyme should not be used in patients with a known hypersensitivity to
dornase alfa, Chinese Hamster Ovary (CHO) cell products (the enzyme is produced
in CHO cells), or any component of the formulation. There is limited clinical
trial data in patients with FVC below 40% predicted, though it may still be
considered at specialist discretion.
Pregnancy: limited data available — discuss with your CF specialist.
⚠ COMPATIBLE NEBULISER ONLY: Pulmozyme must only
be administered via a recommended jet nebuliser. Using an ultrasonic nebuliser
will destroy the enzyme and make the treatment ineffective. Your CF team will
advise which specific nebuliser to use — common compatible devices include the
PARI LC Plus or LC Sprint.
⚠ STORE IN REFRIGERATOR: Pulmozyme must be kept
in the fridge at 2–8°C and protected from light. Do not use ampoules that have
been left unrefrigerated for extended periods or that appear cloudy or
discoloured. Ampoules can be taken out of the fridge for up to 24 hours at room
temperature if needed when travelling.
⚠ SINGLE USE AMPOULES: Each ampoule is for one
treatment session only. Do not store or reuse an opened ampoule.
6. MEDICINES THAT INTERACT WITH THIS TREATMENT
No significant pharmacological drug interactions have been identified
with dornase alfa at recommended doses. It is a locally active enzyme that does
not interact with systemic medicines.
Pulmozyme is fully compatible with the standard CF treatment regimen
including inhaled antibiotics, bronchodilators, and inhaled corticosteroids —
follow your CF team's guidance on the order of nebulised treatments.
7. HOW TO STORE THIS MEDICINE
Store in a refrigerator at 2–8°C. Protect from light. Do not freeze.
Ampoules can be kept at room temperature (up to 30°C) for up to 24 hours (for
travel purposes). Use immediately after opening. Single-use ampoules — discard
any unused portion.
8. PRESCRIPTION REQUIREMENT
|
Field |
Details |
|
Status |
Prescription Only
Medicine (POM) — Specialist (CF centre / respiratory paediatrics or adult
respiratory) prescription required |
9. GUIDANCE FOR PATIENTS & CAREGIVERS
Use one ampoule daily through your jet nebuliser — ideally in the morning
before your chest physiotherapy. Never use an ultrasonic nebuliser — it
destroys the medicine. After your nebuliser session, rinse your mouth and clean
your nebuliser with water and let it dry completely.
Keep ampoules in the fridge at 2–8°C and protect them from light — they
can travel with you for up to 24 hours at room temperature. This treatment is
most effective when used consistently every day as part of your full CF routine
— do not skip doses. If you develop hoarseness, this usually settles — but tell
your CF team if it is persistent or severe.
10. PHARMACIST & PRESCRIBER NOTES
|
Field |
Details |
|
Clinical Dispensing
Notes |
Recombinant human
DNase I — CF mucolytic. Jet nebuliser only — ultrasonic nebulisers deactivate
the enzyme; confirm patient has a compatible jet nebuliser (PARI LC Plus, LC
Sprint, or centre-approved equivalent) before supplying. Do not dilute.
Single-use ampoules. Cold chain: 2–8°C, protect from light; stable at room
temperature (≤30°C) for up to 24 hours for travel. Administer before airway
clearance physiotherapy for maximum mucus clearance benefit. FVC ≥40% is the
standard eligibility criterion — review with CF team if borderline. Monitor
for haemoptysis and allergic reactions. Pregnancy: limited data; risk-benefit
discussion with CF specialist required. Compatible with concurrent inhaled
tobramycin, colistin, bronchodilators, and inhaled steroids — nebuliser order
per CF centre protocol (usually: bronchodilator → Pulmozyme → physiotherapy →
inhaled antibiotics). |
11. FREQUENTLY ASKED QUESTIONS
Q: When is the best time to take it?
Most CF teams recommend using Pulmozyme in the morning, before your
airway clearance physiotherapy session. The enzyme takes 30 to 60 minutes to
thin the mucus, and then the physiotherapy exercises help you clear it out of
your lungs. Using both together gives much better mucus clearance than either
alone.
Q: My cough got worse after I started Pulmozyme — is that bad?
An increase in coughing in the first few days or weeks is actually often
a positive sign — it means the mucus is being broken down and mobilised, and
your airways are clearing more effectively. It usually settles after the first
couple of weeks. If the coughing is very distressing or includes blood, tell
your CF team.
Q: Can I use it if I'm pregnant?
There is limited data on Pulmozyme in pregnancy. Discuss with your CF
specialist — for most people with CF, the benefit of maintaining lung function
outweighs the theoretical risks, but this is an individual decision made with
your specialist team.
Q: Can I travel with Pulmozyme?
Yes — ampoules can be kept out of the fridge at room temperature (below
30°C) for up to 24 hours, which makes travel manageable. For longer trips, you
will need to ensure access to refrigeration. Your CF centre can provide travel
documentation confirming the medicine and its storage requirements if you need
to carry it through airport security.