- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulation of roflumilast.
Chronic obstructive pulmonary disease (FEV1<50% predicted normal)
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.
Roflumilast may need to be taken for several weeks to achieve its effect.
The lower sub-therapeutic starting dose for 28 days is to reduce side effects and patient discontinuation when first starting therapy. This starting dose is followed by a higher maintenance dose.
The tablet should be swallowed with water and taken at the same time every day. The tablet can be taken with or without food.
250micrograms once daily for 28 days.
500micrograms once daily.
Children under 18 years
Active malignancies, except cutaneous basal cell carcinoma
Hepatic impairment - Child-Pugh score greater than 6
History of depression
New York Heart Association class III failure
New York Heart Association class IV failure
Positive HIV status
Progressive multifocal leukoencephalopathy (PML)
Severe immunological disease
Systemic lupus erythematosus
Precautions and Warnings
Females of childbearing potential
Weight below 60kg
Glucose-galactose malabsorption syndrome
Hepatic impairment - Child-Pugh score less than 7
Herpes simplex keratitis
Not suitable for acute treatment of bronchospasm
Ensure patient has a fast acting bronchodilator available
Increased risk of sleep disorders in patient below 60kg
Treatment to be initiated by specialist
Advise patient/carer to record bodyweight regularly on their patient card
Underweight patients: Monitor body weight regularly
Advise patients/carers to seek medical advice if changes in behaviour/mood
Advise patients/carers to seek medical advice if suicidal intent develops
Discontinue if psychiatric disturbances develop
Patient should be made aware of possible adverse effects on mood/behaviour
Discontinue if substantial undesirable weight loss occurs
Discontinue in patients showing depressive behaviour
Discontinue in patients showing suicidal behaviour
Several weeks of treatment may be needed to achieve effect
Advise patient not to take St John's wort concurrently
Female: Ensure adequate contraception during treatment
Advise patient not to use for relief of acute attacks
Pregnancy and Lactation
Roflumilast is contraindicated during pregnancy.
The manufacturer does not recommend using roflumilast during pregnancy.
The manufacturer has noted that there is a limited amount of data from the use of roflumilast in pregnant women.
Studies in animals have shown reproductive toxicity.
Roflumilast has been demonstrated to cross the placenta in animal studies.
Roflumilast is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking roflumilast.
The manufacturer has noted that available pharmacokinetic data in animals has shown excretion of roflumilast or its metabolites in milk. A risk to the suckling child cannot be excluded.
Aspartate aminotransferase increased
Creatine phosphokinase increased
Gamma glutamyl transferase (GGT) increased
Gastroesophageal reflux disease
Respiratory tract infection
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: December 2020
Summary of Product Characteristics: Daxas 250microgram tablets. AstraZeneca UK Limited. Revised May 2020.
Summary of Product Characteristics: Daxas 500microgram tablets. AstraZeneca UK Limited. Revised May 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 October 2019
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.