Rofaday
✅ Reduces lung inflammation
✅ Improves lung function
✅ Treats chronic bronchitis
✅ Decreases COPD exacerbations
✅ Enhances breathing capacity
Rofaday contains Roflumilast.
✓ Medisch beoordeeld door Morgan Ellis — Apotheekonderzoeker · 8 jaar ervaring · Laatst beoordeeld: mei 2026
⚡ Quick Answer — What is Rofaday?
Rofaday bevat roflumilast 500 mcg, an oral selective phosphodiesterase-4 (PDE4) inhibitor taken once daily for severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis phenotype and frequent exacerbations. Roflumilast is anti-inflammatory rather than bronchodilator — it suppresses neutrophil and macrophage activation in airways, reducing exacerbation frequency by ~17% in landmark trials (M2-124, M2-125, REACT). It is added on top of optimal LAMA + LABA (± ICS) in patients with severe disease. Manufactured by Cipla.
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What Is Rofaday?
Rofaday is an oral PDE4 inhibitor for severe COPD. Roflumilast is the only PDE4 inhibitor licensed for COPD — sold internationally as Daxas (AstraZeneca) and Daliresp. It is a niche but well-evidenced add-on for the chronic bronchitis phenotype.
How Does Rofaday Work?
Phosphodiesterase-4 (PDE4) is the dominant cyclic AMP-degrading enzyme in inflammatory cells (neutrophils, macrophages, eosinophils, T-cells). Inhibiting PDE4 raises cyclic AMP in these cells, suppressing:
- Neutrophil chemotaxis and degranulation in airways
- Macrophage cytokine release (TNF-α, IL-8)
- Airway smooth-muscle proliferation and fibroblast activation
- Mucus hypersecretion and goblet-cell hyperplasia
The clinical result is a 15–17% reduction in COPD exacerbation rate when added to optimal inhaled therapy.
Toepassingen en Indicaties
- Severe COPD (FEV1 <50% predicted) with chronic bronchitis and a history of exacerbations, on top of optimal LAMA + LABA (± ICS)
- Frequent exacerbator phenotype with persistent productive cough
Rofaday Dosage
| Patient | Dosering | Frequentie |
|---|---|---|
| Adults — start | 250 mcg for first 4 weeks | Eénmaal daags |
| Adults — maintenance | 500 mcg | Once daily, with or without food |
| Leverfunctiestoornis | Avoid (Child-Pugh B/C) | — |
Side Effects of Rofaday
- Weight loss (averages 2–3 kg in trials — monitor; reverse if >5%)
- Diarrhoea, nausea (commonest reason for discontinuation; usually settles after first 2–4 weeks)
- Hoofdpijn
- Insomnia, anxiety
- Dyspepsia, abdominal pain
- Mood changes — depression, anxiety; rarely suicidal ideation (warning)
Serious — stop and seek help:
- Severe weight loss (>5% body weight)
- New or worsening depression, suicidal thoughts
- Severe persistent diarrhoea
- Ernstige allergische reactie
Waarschuwingen en voorzorgsmaatregelen
- Mood and behaviour: screen for depression before starting; warn patients/families to report new mood symptoms.
- Weight loss: baseline and 3-monthly weight monitoring; if loss exceeds 5%, review or stop.
- Leverfunctiestoornis: avoid in Child-Pugh B and C.
- 4-week dose titration (250 mcg) reduces GI side effects and diarrhoea — most patients can then tolerate 500 mcg.
- Not a bronchodilator — does not replace LAMA, LABA, or ICS.
- Zwangerschap en borstvoeding: contraindicated.
- Drug interactions: CYP3A4 inducers (rifampicin) reduce levels — avoid. Strong CYP1A2 inhibitors (fluvoxamine, ciprofloxacin) raise levels — caution.
Contra-indicaties
- Hypersensitivity to roflumilast
- Moderate-to-severe hepatic impairment (Child-Pugh B/C)
- Zwangerschap
Geneesmiddelinteracties
| Interacting drug | Effect | Wat te doen |
|---|---|---|
| CYP3A4 inducers (rifampicin, phenobarbital, phenytoin, carbamazepine) | Reduce roflumilast levels by 50% | Vermijden |
| Strong CYP1A2 inhibitors (fluvoxamine, ciprofloxacin, enoxacin) | Raise roflumilast levels — increase side effect risk | Caution; consider lower dose |
| Oral contraceptives containing gestodene | Modest increase in roflumilast levels | No dose adjustment usually needed |
Opslag
- Store below 25°C in a cool, dry place away from direct sunlight.
- Keep in original packaging until use to protect from moisture and light.
- Do not use after the expiry date printed on the strip.
- Keep out of reach of children.
Gerelateerde alternatieven op MedsBase
- Asthalin Inhaler — salbutamol reliever
- Budecort Inhaler — budesonide ICS preventer
- Foracort Inhaler — budesonide + formoterol ICS-LABA
- Tiova Inhaler — tiotropium LAMA for COPD
- Montair — montelukast LTRA tablet
Veelgestelde vragen
When is Rofaday added?
For severe COPD (FEV1 <50% predicted) with chronic bronchitis phenotype and a history of frequent exacerbations on top of optimal LAMA + LABA (± ICS). Not for mild COPD or asthma.
Why must I start at 250 mcg?
A 4-week titration at 250 mcg dramatically reduces GI side effects (diarrhoea, nausea) — most patients can then move to the maintenance 500 mcg without intolerance.
How much does Rofaday reduce exacerbations?
About 15–17% reduction in moderate-to-severe COPD exacerbations in landmark trials (M2-124, M2-125, REACT). Most benefit seen in the chronic bronchitis with frequent exacerbator phenotype.
Will Rofaday make me lose weight?
Yes — average 2–3 kg in trials. Monitor weight at baseline and every 3 months. If loss exceeds 5%, review indication or stop.
What about mood changes?
Rare but reported. Screen for depression at baseline; counsel patient and family to report new mood symptoms, anxiety, or suicidal thoughts. Stop and review.
Is Rofaday a bronchodilator?
No — it is anti-inflammatory only. Continue your LAMA, LABA, and (where indicated) ICS inhalers.
Can I take Rofaday during pregnancy?
Contraindicated.
How does Rofaday compare to triple therapy?
Triple inhaler (Triohale) and Rofaday tackle COPD exacerbations through different mechanisms (bronchodilation + inflammation suppression vs PDE4-mediated anti-inflammation). Some patients benefit from both.
What are the most important drug interactions?
Rifampicin (and other CYP3A4 inducers) reduce Rofaday levels by half — avoid. Strong CYP1A2 inhibitors (fluvoxamine, ciprofloxacin) raise levels — caution.
Gerelateerde alternatieven
Andere producten in Chronische aandoeningen die klanten ook bekijken:
More options in Asthma/COPD Treatment
Gerangschikt op recente bestelvolumes van MedsBase — wat andere klanten in deze categorie kiezen.
| Sterkte | 500 mcg |
|---|---|
| Hoeveelheid | 30 Tabletten, 60 Tabletten, 90 Tabletten, 180 Tabletten |
Rofaday
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