Immunology:
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      • Skyrizi Logo White

      Safety

      » Established safety profile in PsO and PsA1-5

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      • Rates of serious AEs, AEs leading to discontinuation and AEs of safety interests remained comparable with the rates observed in the clinical development program2,3
      • No cases of systemic candidiasis or active tuberculosis were observed2,3
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      CONTRAINDICATIONS1

      • Patients with hypersensitivity to the active substance or to any of the excipients
      • Clinically important active infections

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      Infections

      SKYRIZI® may increase the risk of infections. In patients with a chronic infection or a history of recurrent infection, the risks and benefits should be considered prior to prescribing SKYRIZI®. Patients should be instructed to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and SKYRIZI® should not be administered until the infection resolves.

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      Tuberculosis

      Prior to initiating treatment with SKYRIZI®, patients should be evaluated for tuberculosis (TB) infection. SKYRIZI® must not be given to patients with active TB. Patients receiving SKYRIZI® should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI® in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

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      Immunisations

      Prior to initiating therapy with SKYRIZI®, completion of all appropriate immunisations should be considered according to current immunisation guidelines. SKYRIZI® should not be used with live vaccines.

      Abbreviations: AE, adverse event; b/cs/DMARDs, biologic/conventional synthetic/disease-modifying anti-rheumatic drugs; CI, confidence interval; E/100 PY, events per 100 patient years; MACE, major adverse cardiovascular event; NMSC, non-melanoma skin cancer; PsA, psoriatic arthritis; PsO, psoriasis; PSOLAR, Psoriasis Longitudinal Assessment and Registry; PY, patient year; TEAE, treatment-emergent adverse event.

      References: 1. SKYRIZI Approved Datasheet. 2. Papp KA et al. Br J Dermatol 2021;185(6):1135–1145. 3. Papp KA et al. Poster presented at: the 31st Congress of the European Academy of Dermatology and Venerology, 7–10 September 2022. P1603. 4. Kristensen LE et al. Ann Rheum Dis 2022;81(2):225–31. 5. Östör A et al. Ann Rheum Dis 2022;81(3):351–8.

      PBS Information

      SKYRIZI: Authority required for the treatment of adults with severe plaque psoriasis. SKYRIZI is not listed on the PBS for the treatment of psoriatic arthritis. Refer to PBS Schedule for full authority information.

      Please review the full Product Information (PI) before prescribing, available below.

      SKYRIZI PI

      AU-SKZD-210067. April 2024