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Drugs List

  • apremilast 10mg tablets and 20mg tablets and 30mg tablets
  • apremilast 30mg tablets
  • OTEZLA 30mg tablets
  • OTEZLA 10mg + 20mg + 30mg tablets TREATMENT INITIATION PACK
  • Therapeutic Indications


    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.

    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.



    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.


    Children under 18 years

    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


    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.


    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
    Back pain
    Decreased appetite
    Gastro-intestinal haemorrhage
    Gastroesophageal reflux disease
    Hypersensitivity reactions
    Psychiatric disorders
    Suicidal tendencies
    Upper abdominal pain
    Upper respiratory tract infection
    Weight loss


    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 ( ) or if this is unavailable at the backup site ( ).

    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: Last accessed: 07 August 2019

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