2 The technology

2 The technology

Description of the technology

Roflumilast (Daxas, AstraZeneca) is an orally administered long-acting selective phosphodiesterase-4 enzyme inhibitor. It targets cells and mediators believed to be important in chronic obstructive pulmonary disease (COPD).

Marketing authorisation

Roflumilast has a marketing authorisation in the UK for maintenance treatment of severe COPD (forced expiratory volume in the first second [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.

Adverse reactions

The most common adverse reactions associated with roflumilast include diarrhoea, weight loss, nausea, abdominal pain and headache. Roflumilast is subject to additional monitoring for weight loss. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

The recommended dose is 500 micrograms (1 tablet) of roflumilast once daily.

Price

£37.71 for 30 tablets and £113.14 for 90 tablets (excluding VAT; 'British national formulary' [BNF] edition 72). Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)