Roflumilast

Amber-G

Brand Name(s):Daxas

Indication:Severe chronic obstructive pulmonary disease (COPD)

Rationale:

Considered:May-10

Review Date:Sep-23

Comments:
Roflumilast for treating chronic obstructive pulmonary disease
Technology appraisal guidance [TA461] Published date: 26 July 2017
LINK; https://www.nice.org.uk/guidance/ta461
Roflumilast is available for the management of COPD, where considered clinically appropriate in accordance with NICE guidance. Roflumilast should only be initiated by a consultant respiratory physician and the side effects of the medication should be considered closely for each individual patient when assessing suitability of the product.
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Refer to formulary (NICE)
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Roflumilast (Daxas): risk of suicidal behaviour, avoid use in patients with previous or existing psychiatric symptoms and discontinue treatment if new or worsening psychiatric symptoms occur

Advice for healthcare professionals:
Roflumilast is not recommended for patients with a history of depression associated with suicidal ideation or behaviour
Patients and caregivers should be asked to notify the prescriber and their healthcare provider of any changes to behaviour or mood, and any suicidal ideation. Such symptoms include preoccupation with suicidal thoughts, and self-harm.
Roflumilast should be discontinued if new or worsening psychiatric symptoms or suicidal behaviour are identified
Further information available at:
http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON228753
Article date: January 2013
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NICE technology appraisal guidance 244
Roflumilast for the management of severe chronic obstructive pulmonary disease
Guidance
Roflumilast is recommended only in the context of research as part of a clinical trial for adults with severe chronic obstructive pulmonary disease (COPD) (for the purposes of this guidance defined as forced expiratory volume in 1 second [FEV1] post-bronchodilator less than 50% predicted) associated with chronic bronchitis with a history of frequent exacerbations as an add-on to bronchodilator treatment.

Such research should be designed to generate robust evidence about the benefits of roflumilast as an add-on to long-acting muscarinic antagonists (LAMA) plus long-acting beta2 agonists (LABA) plus inhaled corticosteroids (ICS), or LAMA plus LABA for people who are intolerant to ICS.

People receiving roflumilast should have the option to continue treatment until they and their clinicians consider it appropriate to stop.
Issued: January 2012
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