Apremilast oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Drugs List
Therapeutic Indications
Uses
Moderate to severe plaque psoriasis: Second line treatment
Oral ulcers associated with Behcet's disease
Psoriatic arthritis when inadequate response or intolerant to prior DMARDs
Psoriatic arthritis
Apremilast, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
Psoriasis
Apremilast is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who have failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).
Behcet's disease
Apremilast is indicated for the treatment of adult patients with oral ulcers associated with Behcet's disease (BD) who are candidates for systemic therapy.
Dosage
Adults
The recommended dose of apremilast is 30mg twice daily, morning and evening, approximately 12 hours apart.
Titration schedule
Day 1
Morning: 10mg
Day 2
Morning: 10mg
Evening: 10mg
Day 3
Morning: 10mg
Evening: 20mg
Day 4
Morning: 20mg
Evening: 20mg
Day 5
Morning: 20mg
Evening: 30mg
Day 6 and thereafter
Morning: 30mg
Evening: 30mg
Patients with Renal Impairment
Severe renal impairment (creatinine clearance less than 30ml/minute)
The dose should be reduced to 30mg once daily.
For initiation in this group, it is recommended that apremilast be titrated using only the morning schedule and the evening doses be skipped.
Additional Dosage Information
If a patient misses a dose, the next dose should be taken as soon as possible. If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time.
Psoriatic arthritis and Psoriasis
If a patient shows no evidence of therapeutic benefit after 24 weeks, treatment should be reconsidered.
Behcet's disease
If a patient shows no evidence of therapeutic benefit after 12 weeks, treatment should be reconsidered.
Contraindications
Children under 18 years
Breastfeeding
Galactosaemia
Pregnancy
Precautions and Warnings
Females of childbearing potential
Patients over 65 years
Glucose-galactose malabsorption syndrome
History of psychiatric disorder
Lactose intolerance
Renal impairment - creatinine clearance below 30 ml/minute
Reduce dose in patients with severe renal impairment
Treatment to be initiated and supervised by a specialist
Contains lactose
Exclude pregnancy prior to initiation of treatment
Monitor for depressive disorders/suicidal ideation-consider discontinuation
Monitor patients with a history of depression and/or suicide attempts
Underweight patients: Monitor body weight regularly
Consider discontinuing if severe diarrhoea nausea or vomiting occur
Discontinue if psychiatric disturbances develop
Patient should report worrying psychological changes esp. suicidal thoughts
Consider stopping if unexplained/clinically significant weight loss occurs
Discontinue if depression worsens or recurs
Advise patient not to take St John's wort concurrently
Female: Ensure adequate contraception during treatment
Elderly patients are at increased risk of complications from severe diarrhoea, nausea and vomiting which may require discontinuation of apremilast.
Pregnancy and Lactation
Pregnancy
Apremilast is contraindicated during pregnancy.
Use of apremilast during pregnancy is contraindicated by the manufacturer. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Apremilast is contraindicated during breastfeeding.
Use of apremilast when breastfeeding is contraindicated by the manufacturer. Animal data reports significant levels of apremilast in the breast milk, however presence in human breast milk is unknown.
Side Effects
Altered bowel habit
Angioedema
Back pain
Bronchitis
Cough
Decreased appetite
Depression
Diarrhoea
Dyspepsia
Fatigue
Gastro-intestinal haemorrhage
Gastroesophageal reflux disease
Headache
Hypersensitivity reactions
Insomnia
Migraine
Nasopharyngitis
Nausea
Psychiatric disorders
Rash
Suicidal tendencies
Upper abdominal pain
Upper respiratory tract infection
Urticaria
Vomiting
Weight loss
Overdosage
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 ).
Further Information
Last Full Review Date: August 2019
Reference Sources
Summary of Product Characteristics: Otezla 10mg, 20mg, 30mg treatment initiation pack. Celgene Ltd. Revised April 2020.
Summary of Product Characteristics: Otezla 30mg tablets. Celgene Ltd. Revised April 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 August 2019
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.