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Roflumilast launched as add-on COPD treatment

by News team

Roflumilast, a new medicine for chronic obstructive pulmonary disease, is now available from Merck Sharp & Dohme.

Launched earlier this month under the brand name Daxas, the drug is an add-on to existing bronchodilator treatment and is indicated for maintenance treatment of severe COPD associated with chronic bronchitis in adults with a history of frequent exacerbations.

Patients should check their weight regularly and if an unexplained or clinically concerning weight loss occurs, roflumilast treatment should be stopped. In one-year studies, patients regained body weight by three months after discontinuation, the summary of product characteristics states.

Roflumilast is also associated with an increased risk of psychiatric disorders such as insomnia, anxiety, nervousness and depression.

Adverse effects, including diarrhoea, nausea, abdominal pain and headache, occur mainly in the first few weeks of treatment and most resolve with continued treatment, but in cases of persistent intolerability treatment should be stopped.

The drug may take several weeks to achieve its effects, according to the SPC.

NPC logoOral roflumilast launched as add-on treatment for COPD

Product information

Action Phosphodiesterase type 4 inhibitor

Dose 500µg tablet once daily at the same time every day with or without food

Cost 30 x 500µg tablets, £37.71; 90 x 500µg tablets, £113.14


Citation: The Pharmaceutical Journal URI: 11026361

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Supplementary images

  • Daxas pack shot

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