WHAT IS THIS MEDICINE?
Daxas contains roflumilast, a selective phosphodiesterase-4
(PDE4) inhibitor. Blocking PDE4, it reduces inflammation in the lungs
without the systemic side effects of corticosteroids. It is used as an add-on
treatment to bronchodilators in adults with severe COPD associated with chronic
bronchitis and a history of frequent exacerbations (flare-ups).
2. HOW TO TAKE THIS MEDICINE
Take 250 mcg once daily for 4 weeks, followed by 500 mcg once
daily. The initial dose of 250 mcg once daily is recommended for the first 4
weeks of treatment in an attempt to improve tolerability, with or without
food. Swallow whole with water.
Daxas is an add-on therapy — it does not replace inhaled
bronchodilators or corticosteroids. It does not provide quick relief and should
not be used as a rescue treatment. Consistent daily use is required for
benefit.
3. POSSIBLE SIDE EFFECTS
Common side effects include the following. Contact your
doctor or pharmacist if any side effect worries you.
|
Side Effect |
Frequency |
What To Do |
|
Diarrhoea |
Common |
Usually in the first 4 weeks; resolves with
continued use |
|
Nausea |
Common |
Take with food to reduce nausea |
|
Weight loss |
Common |
Monitor weight regularly; report significant
loss |
|
Headache |
Common |
Usually transient; paracetamol if needed |
|
Insomnia/sleep disorder |
Common |
Avoid taking it late in the evening |
|
Depression/anxiety |
Uncommon |
Report mood changes promptly; stop if severe |
|
Suicidal ideation |
Rare |
Seek immediate help — contact a doctor/emergency
services |
4. WHO SHOULD NOT TAKE THIS MEDICINE
Contraindicated in moderate-to-severe liver impairment
(Child-Pugh B or C). Not suitable for use as monotherapy or in mild COPD. Not
licensed for acute bronchospasm. Do not use in pregnancy or breastfeeding. Do
not use concurrently with theophylline (insufficient evidence of combination
safety).
5. DRUG INTERACTIONS
Rifampicin, phenobarbitone, carbamazepine, and phenytoin
reduce roflumilast blood levels (reduced effect). Erythromycin, ketoconazole,
fluvoxamine, and oral contraceptives (especially enoxacin + gestodene)
significantly increase roflumilast levels — use combination with caution.
CYP1A2 and CYP3A4 interactions are clinically relevant.
6. HOW TO STORE
Store below 30°C. Keep in original packaging. Protect from
light and moisture. Keep out of reach of children.
7. PRESCRIPTION STATUS
Prescription Only Medicine (POM). Specialist-initiated
(respiratory physician). Patients should be reviewed regularly to assess
benefit and tolerability.
|
💚 PATIENT TIP |
|
Weigh yourself once a week while on Daxas and
record it. Weight loss of more than 5% of body weight is a reason to contact
your doctor and review your treatment. Early monitoring helps prevent
significant nutritional decline. |
8. PHARMACIST'S NOTE
Counsel patients that gastrointestinal side effects are
common in the first 4 weeks and usually resolve — early discontinuation due to
tolerability is frequent but avoidable with counselling. Weight loss is common
and should be monitored — patients who are already underweight at baseline may
not be suitable candidates. Psychiatric history should be confirmed before
dispensing.
9. FREQUENTLY ASKED QUESTIONS
|
FREQUENTLY ASKED QUESTIONS |
|
Q: What type of COPD is
Daxas used for? A: Daxas is used for severe COPD (FEV1 <50%
predicted) in patients with chronic bronchitis and at least one COPD
exacerbation in the past year, as add-on therapy to long-acting
bronchodilators. |
|
Q: Will Daxas help me
breathe better immediately? A: No — Daxas works over weeks to months by
reducing underlying inflammation and preventing exacerbations. For immediate
breathing relief, continue using your prescribed inhalers (LABA, LAMA, ICS). |
|
Q: Should I stop Daxas if
I feel depressed? A: Contact your doctor before stopping. If you
experience suicidal thoughts, stop immediately and seek emergency help.
Depression as a side effect of roflumilast is recognised, and your doctor may
switch to an alternative. |
|
Q: Can Daxas be used with
my inhaled steroids? A: Yes — Daxas can be combined with inhaled
corticosteroids (ICS), long-acting beta-agonists (LABAs), and long-acting
muscarinic antagonists (LAMAs). It provides complementary anti-inflammatory
activity. |
|
Q: Is Daxas suitable for
asthma? A: No — roflumilast is not licensed or
recommended for asthma. It is specifically for COPD with a chronic bronchitis
phenotype and frequent exacerbations. |
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