What is Daxas?
Daxas is an oral phosphodiesterase-4 inhibitor (PDE4 inhibitor) containing the active ingredient roflumilast. It is taken as a tablet and is used as add-on maintenance therapy for severe COPD with frequent exacerbations.
Roflumilast has an anti-inflammatory effect and is a selective PDE4 inhibitor developed specifically for COPD therapy. It is used in addition to bronchodilator inhalers and reduces the frequency of COPD flare-ups.
Daxas is manufactured by AstraZeneca and is available as 250 µg and 500 µg tablets.
Active Ingredients & Mechanism of Action
Active ingredient: Roflumilast
Roflumilast inhibits the enzyme phosphodiesterase 4:
Mechanism of action: 1. PDE4 breaks down cAMP inside cells 2. Roflumilast selectively inhibits PDE4 3. cAMP levels in inflammatory cells rise 4. The inflammatory response is dampened
Effects:
- Reduction of neutrophils and eosinophils in the airways
- Decreased mucus production
- Anti-inflammatory effect
- Reduction of COPD exacerbations
Important difference from theophylline: Roflumilast selectively inhibits PDE4, whereas theophylline acts non-selectively.
Who is it suitable for?
Daxas is suitable for:
- Severe COPD (FEV1 < 50%) with chronic bronchitis
- Frequent exacerbations despite standard therapy
- As an add-on to bronchodilator inhaler therapy
Not suitable:
- For asthma (not approved)
- In mild or moderate COPD
- As the sole COPD therapy
- In moderate to severe liver impairment (Child-Pugh B/C)
Important: Daxas is an add-on therapy – it does not replace inhalers!
Available Dosages
Daxas tablets:
- 250 µg (starting dose)
- 500 µg (maintenance dose)
Dosing schedule:
- First 28 days: 250 µg once daily (gradual start)
- From day 29: 500 µg once daily
- Once daily, regardless of meals
Note: The gradual start over 4 weeks considerably reduces gastrointestinal side effects.
Dosage form and pack sizes
The medicines catalogue lists 2 pack variants: one strength in 2 pack sizes. Pack sizes range from 30 to 90 units.
- Dosage form
- Filmtablette
- Strengths
- 500 µg
- Pack sizes
- 30 units, 90 units
| Strength | Pack | PZN | Duration |
|---|---|---|---|
| 500 µg | 30 units | 07776844 | 30 days |
| 500 µg | 90 units | 09393219 | 90 days |
Packs listed in the German medicines catalogue. Which of them are currently available and what they cost is shown in the price overview.
The Pharmazentralnummer (PZN) is the nationwide unique identifier of a pack in Germany.
Duration is the catalogue value for the usual dosage. How long a pack actually lasts depends on the dose your doctor prescribes.
How to Take
How to take:
- 1 tablet daily with a little water
- Regardless of meals
- Always at the same time of day
- Start with 250 µg for 4 weeks, then 500 µg
Important notes:
- Be patient: full effect only after weeks
- Gastrointestinal side effects usually improve after 2-4 weeks
- Monitor changes in weight
Contraindications
Do not use in case of:
- Hypersensitivity to roflumilast
- Moderate to severe liver impairment (Child-Pugh B/C)
Use with caution in case of:
- Pre-existing psychiatric conditions (depression, suicidality)
- Underweight
- Latent infections (tuberculosis, herpes, HIV)
- Concurrent immunosuppressive therapy
Pregnancy: Not recommended. Effective contraception is necessary.
Breastfeeding: Do not use.
Possible Side Effects
Common (1-10%):
- Diarrhea (especially at the start)
- Nausea
- Weight loss
- Headache
- Abdominal pain
- Sleep disturbances
- Decreased appetite
Uncommon:
- Tremor
- Dizziness
- Stomach discomfort
Rare but important:
- Depressed mood
- Suicidal thoughts
Important: If you notice mood changes or significant weight loss, inform your doctor immediately!
Interactions
Interactions:
- CYP3A4/CYP1A2 inhibitors – can increase roflumilast levels
- Rifampicin – lowers roflumilast levels (loss of effect)
- Theophylline – not recommended (additive PDE inhibition)
- Immunosuppressants – increased risk of infection
No relevant interaction with:
- Inhaled bronchodilators
- Inhaled corticosteroids
Frequently Asked Questions
Daxas is only approved for severe COPD, not for asthma. For asthma, other, more suitable medications are available.
The gradual start over 4 weeks considerably reduces the common gastrointestinal side effects (diarrhea, nausea). Most side effects occur at the beginning and then improve.
Weight loss is a known side effect of roflumilast. In case of significant weight loss (>10% of body weight), the therapy should be reviewed. Regular weighing is recommended.
Similar Medications
Is Daxas right for you?
A licensed doctor will review your information and issue a prescription if suitable. Discreet and secure.
Important Notice
This information does not replace medical advice. If you have questions about your health or the suitability of this medication, please consult a doctor or pharmacist.
Important Safety Information
This service operates under German pharmaceutical law (HWG). For risks and side effects, read the package leaflet and consult your doctor or pharmacist. All medications are dispensed from a licensed pharmacy in Germany.