OTEZLA® has a favourable safety profile that is maintained long-term1,2

ǂIncludes all patients who received ≥1 dose of OTEZLA®, regardless of when they were randomised.1,3
†3 years in patients with moderate to severe psoriasis, and 5 years in patients with active PsA.1,2

  • Indication

    OTEZLA® (apremilast) is indicated for the treatment of:6

    Psoriasis

    • Moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA)

    Psoriatic arthritis

    • Alone, or in combination with Disease Modifying Antirheumatic Drugs (DMARDs) for active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy
  • Dosing6

    The recommended dose of OTEZLA® is 30 mg taken orally twice daily, approximately 12 hours apart (morning and evening), with no food restrictions. An initial titration schedule is required as shown below in Table 1. No re-titration is required after initial titration.

    Table 1. Dose titration schedule6
    line-chart line-chart

    Patients with renal impairment

    No dose adjustment is needed in patients with mild and moderate renal impairment. The dose of apremilast should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockcroft-Gault equation). For initial dose titration in this group, it is recommended that apremilast be titrated using only the AM schedule listed in Table 1 and the PM doses be skipped.

AE, adverse event; HCP, healthcare professional; MTX, methotrexate; PsA, psoriatic arthritis; URTI, upper respiratory tract infection.

  • References
    1. Crowley J, el al. JAm Acad Dermatol. 2017:77(2): 310-317:
    2. Kavanaugh A. et al. Arthritis Res Ther. 2019;21:118;
    3. Mease PJ, et al. Poster presented at the Annual Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACRIARHP): 26-30 October 2013: San Diego, CA: #310:
    4. Papp KA, et al. Presented at the 74th Annual Meeting of the American Academy of Dermatology; March 4-8, 2016; Washington, DC. 2347;
    5. Mease PJ, et al. Presented at the Annual European Congress of Rheumatology (European League Against Rheumatism); 11-14 June 2014; Paris, France #SAR0408
    6. OTEZLA® (apremilast) Summary of Product Characteristics
    7. Methotrexate 25 mg/mL injection. Summary of Product Characteristics;
    8. Tofacitinib. Summary of Product Characteristics,
    9. Upadacitinib. Summary of Product Characteristics;
    10. Reich K, et al. Dermatol Ther (Heidelb) 2022; 12:203–221
    11. Augustin M. et al. J Eur Assoc Dermatol Venereol. 2021:35:123-134
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  • Adverse Event Reporting Information
    Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Amgen Limited on +44 (0) 1223 436441.