Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
The recommended starting dose is one tablet of 250 micrograms roflumilast to be taken once daily, for 28 days.
This starting dose is intended to reduce adverse events and patient discontinuation when initiating therapy, but it is a sub-therapeutic dose. Therefore, the 250-micrograms dose should be used only as a starting dose (see sections 5.1 and 5.2).
After 28 days of treatment with the 250-micrograms starting dose, patients must be up-titrated to one tablet of 500 micrograms roflumilast, to be taken once daily.
Roflumilast 500 micrograms may need to be taken for several weeks to achieve its full effect (see sections 5.1 and 5.2). Roflumilast 500 micrograms has been studied in clinical trials for up to one year, and is intended for maintenance treatment.
No dose adjustment is necessary.
No dose adjustment is necessary.
The clinical data with roflumilast in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Daxas should be used with caution in these patients.
Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Daxas (see section 4.3).
There is no relevant use of Daxas in the paediatric population (under 18 years) for the indication of COPD.
For oral use.
The tablet should be swallowed with water and taken at the same time every day. The tablet can be taken with or without food.
In Phase I studies, the following symptoms were observed at an increased rate after single oral doses of 2,500 micrograms and one single dose of 5,000 micrograms (ten times the recommended dose): headache, gastrointestinal disorders, dizziness, palpitations, light-headedness, clamminess and arterial hypotension.
In case of overdose, it is recommended that the appropriate supportive medical care is provided. Since roflumilast is highly protein bound, haemodialysis is not likely to be an efficient method of its removal. It is not known whether roflumilast is dialysable by peritoneal dialysis.
4 years.
This medicinal product does not require any special storage conditions.
PVC/PVDC aluminium blisters in packs of 28 tablets.
No special requirements.
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