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      RINVOQ’s safety profile has been established across a robust clinical trial platform involving more than 4,000 patients and more than 3,400 patient-years of exposure*2

      *Patients received RINVOQ 15mg and in certain studies upadacitinib 30mg.2 The approved dose of RINVOQ is 15mg QD. Upadacitinib 30mg QD is not an approved dose,1 therefore results including this dose are not included in this portal.

      QD, Once Daily.

      WELL-CHARACTERISED safety profile across multiple patient populations in 5 Phase 3 studies3

      Integrated safety analysis3

      In patients with moderate to severe active RA.1,3

      Integrated safety analysis of 5 Phase 3 studies, which included SELECT-NEXT, -BEYOND, -MONOTHERAPY, -COMPARE and –EARLY.3

      *MTX pooled includes patients on MTX monotherapy censored at time of rescue to combination therapy (either to RINVOQ + MTX or addition of csDMARDs).3 
      MACE was defined as cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.3
      VTE was defined as deep vein thrombosis and pulmonary embolism.3
      §Deaths included non–treatment-emergent deaths (3 on RINVOQ and 1 on adalimumab).3

      csDMARD, conventional synthetic Disease-Modifying Anti­-Rheumatic Drug; EOW, Every Other Week; MTX, Methotrexate; PY, Patient-Year; QD, Once Daily; RA, Rheumatoid Arthritis.


      • Hypersensitivity to the active substance or to any of the excipients
      • Active tuberculosis (TB) or active serious infections
      • Severe hepatic impairment
      • Pregnancy

      Summary of the RINVOQ safety profile

      The most commonly reported adverse drug reactions are upper respiratory tract infections (13.5%), nausea (3.5%), blood creatine phosphokinase (CPK) increased (2.5%), and cough (2.2%). The most common serious adverse reactions were serious infections.1

      Adverse drug reactions1

      A total of 2,630 RA patients received at least one dose of RINVOQ 15mg QD in the 5 Phase 3 studies.2 Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

      *URTI includes: acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection.1 
      Herpes simplex includes oral herpes.1

      ALT, Alanine Aminotransferase; AST, Aspartate Aminotransferase; CPK, Creatine Phosphokinase; QD, Once Daily; RA, Rheumatoid Arthritis; URTI, Upper Respiratory Tract Infections.

      Monitoring requirements1

      Treatment with RINVOQ should not be initiated if:

      • Absolute neutrophil count <1,000 cells/mm3*
      • Absolute lymphocyte count <500 cells/mm3*
      • Hemoglobin levels <8g/dL*

      *Treatment may be initiated or restarted after levels return above specified values.1

      Laboratory measures and monitoring guidance1

      Special populations1


      No dose adjustment is required in patients aged 65 years and older. There are limited data in patients aged 75 years and older.

      Renal impairment

      No dose adjustment is required in patients with mild or moderate renal impairment. There are limited data on the use of RINVOQ in subjects with severe renal impairment. RINVOQ should be used with caution in patients with severe renal impairment. The use of RINVOQ has not been studied in subjects with end-stage renal disease.

      Hepatic impairment

      No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. RINVOQ should not be used in patients with severe (Child Pugh C) hepatic impairment.

      Paediatric population

      The safety and efficacy of RINVOQ in children and adolescents aged 0 to less than 18 years have not yet been established. No data are available.


      1. RINVOQ (upadacitinib) Summary of Product Characteristics, available at www.medicines.ie.
      2. European Medicines Agency. RINVOQ: EPAR - Public Assessment Report. EMA/608624/2019 Corr. 1. Available from: https://www.ema.europa.eu/en/documents/assessment-report/rinvoq-epar-public-assessment-report_en.pdf [Accessed June 2020].
      3. Cohen S, van Vollenhoven R, Winthrop K, et al. Safety Profile of Upadacitinib in Rheumatoid Arthritis: Integrated Analysis from the SELECT Phase 3 Clinical Program [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). Available from: https://acrabstracts.org/abstract/safety-profile-of-upadacitinib-in-rheumatoid-arthritis-integrated-analysis-from-the-select-phase-3-clinical-program/ [Accessed June 2020].

      Date of preparation: June 2020  IE-RNQR-200011

      RINVOQ HUMIRA – Legal Category: POM (S1A).
      Further information is available on request from AbbVie Limited, 14 Riverwalk, Citywest Business Campus, Dublin 24, Ireland.


      ▼ 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 via HPRA Pharmacovigilance, website: www.hpra.ie