Immunology:
Our other therapy areas

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      INITIATION GUIDE
      PRODUCT INFORMATION
      PATIENT BOOKLET
      RINVOQ CD banner

      RINVOQ® (upadacitinib) is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease, who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological medicine.1

      WARNING: Based on the results from a post-marketing safety study of another JAK inhibitor, RINVOQ should only be used if no suitable treatment alternatives are available in patients:
      • With history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long time smokers).
      • With malignancy risk factors (e.g. current malignancy or history of malignancy).
      • Who are 65 years of age and older.

      Refer to Product Information.

      RINVOQ achieved the two co-primary endpoints of disease control:
      endoscopic response (per simple endoscopic score for Crohn’s disease [SES-CD]) and clinical remission (per stool frequency and abdominal pain score [SF/APS]) at Week 12 and Week 521,2

      ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

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      Safety profile established in 22 Phase 3 RINVOQ trials1,3-7

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      >17,500

      PATIENT-YEARS SAFETY EXPERIENCE
      ACROSS ALL INDICIATIONS1

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      22PHASE 3
      TRIALS1,3-7
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      7APPROVED INDICATIONS IN RHEUMATOLOGY, DERMATOLOGY & GASTROENTEROLOGY1

      *RINVOQ 15mg

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      Ulcerative colitis

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      RINVOQ is indicated for the treatment of adult patients with moderate to severe active ulcerative colitis, who have had inadequate response, loss of response or intolerance to conventional or biological medicine.

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      Crohn's Disease

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      RINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn's disease, who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological medicine.

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      Atopic dermatitis

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      RINVOQ is indicated for use in adults and adolescents aged 12 years and above who weigh at least 40 kg, for the treatment of moderate to severe atopic dermatitis which is inadequately controlled with active topical pharmacotherapies and for whom systemic therapy is indicated.

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      Rheumatoid arthritis

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      RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs).

      RINVOQ may be used as monotherapy or in combination with methotrexate or other conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).

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      Ankylosing spondylitis

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      RINVOQ is indicated for the treatment of adults with active ankylosing spondylitis.

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      Psoriatic arthritis

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      RINVOQ is indicated for the treatment of moderate to severe active psoriatic arthritis in adult patients who have responded inadequately to or are intolerant to one or more DMARDs.

      RINVOQ may be used as monotherapy or in combination with a non-biological DMARD.

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      Non-radiographic
      Axial Spondyloarthritis

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      RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) change, who have responded inadequately to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

      AD: atopic dermatitis; AS: ankylosing spondylitis; ESS: endoscopic subscore; NRI-C: non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19; PsA: psoriatic arthritis; QD: once-daily; RA: rheumatoid arthritis; RBS: rectal bleeding score;

      REFERENCES

      1. RINVOQ Product Information.
      2. Loftus EV, et al. N Engl J Med. 2023;388:1966–80 (incl. supplementary appendix).
      3. Kameda H, et al. Rheumatology (Oxford). 2020;59(11):3303–13.
      4. Zeng X, et al. Int J Rheum Dis. 2021;24(12):1530–9.
      5. Rubbert-Roth A, et al. N Engl J Med. 2020;383(16):1511–21.
      6. Katoh N, et al. Dermatol Ther (Heidelb). 2023;13(1):221–34.
      7. Blauvelt A, et al. JAMA Dermatol. 2021;157(9):1047–55.

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      WARNING: Based on the results from a post-marketing safety study of another JAK inhibitor, RINVOQ should only be used if no suitable treatment alternatives are available in patients:
      • With history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long time smokers).
      • With malignancy risk factors (e.g. current malignancy or history of malignancy).
      • Who are 65 years of age and older.

      Refer to Product Information.

      PBS Information

      RINVOQ: Authority required. Refer to PBS Schedule for full authority information.

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

      RINVOQ PI

      AU-RNQG-240044. March 2024