Immunology:
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      • RINVOQ (upadacitinib) logo
      INITIATION GUIDE
      PRODUCT INFORMATION
      PATIENT BOOKLET
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      Induction
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      The recommended induction dose of RINVOQ is 45 mg once daily for 8 weeks

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      Week 0-8: Induction (8 weeks)

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      Week 9-16: Extended induction (+ 8 weeks)
      Induction may be continued for an additional 8 weeks for patients who do not achieve adequate therapeutic benefit by Week 8.

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      REVIEW RESPONSE
      Discontinue if a satisfactory clinical response is not achieved at the end of extended induction (after 16 weeks).

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      For patients ≥ 65 years of age, the recommended maintenance dose is 15 mg once daily.

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      Maintenance

      The recommended dose of RINVOQ for maintenance treatment is 15 mg once daily.

      Use the lowest effective dose needed to maintain a clinical response.

      A dose of 30 mg once daily may be considered for:

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      Patients with refractory, severe or extensive disease

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      Patients who do not show a satisfactory clinical response to 15 mg once daily.

      Discontinue treatment if a satisfactory clinical response is not achieved with the 30 mg dose.

      RINVOQ is to be taken orally once daily with or without food & should be taken at about the same time each day. Tablets should be swallowed whole and should not be split, crushed, or chewed.2

      Full information about RINVOQ’s dosing information in UC can be found in the product information.

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      *No evaluable data are available on the use of RINVOQ in stage 5 kidney disease; RINVOQ has not been studied in patients with end stage renal disease (eGFR <15mL/min/1.73m2). No dose adjustment is recommended for patients with stage 2 kidney disease. Patients with kidney disease stages 3 to 5 (GFR <60 mL/min/1.73 m2) may have increased plasma exposures to RINVOQ which may increase potential for adverse events.

      Please note tablets not actual size.

       

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      The use of RINVOQ is contraindicated in patients:

      • Who are hypersensitive to the active substance or to any of the excipients
      • Who are using biologic DMARDs
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      • The safety and efficacy of RINVOQ in children and adolescents with ulcerative colitis aged 0 to less than 18 years have not yet been established. No data are available.
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      • RINVOQ should only be used in patients ≥65 years if no suitable treatment alternatives are available.
      • There are limited data in patients aged 75 and older.
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      • No dose adjustment is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.
      • RINVOQ is not recommended for use in patients with severe hepatic impairment (Child-Pugh C).
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      • RINVOQ should not be used during pregnancy (category D) or during breastfeeding.
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      RINVOQ should not be initiated in patients with:

      • Absolute lymphocyte count <0.5 x109 cells/L*
      • Absolute neutrophil count <1 x109 cells/L*
      • Haemoglobin <80 g/L (<8 g/dL)*

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

      Please consult the product information for further details regarding contraindications, monitoring requirements and additional prescribing information prior to initiating RINVOQ

      See RINVOQ's Product Information

      CYP3A4: cytochrome P3A4; UC: ulcerative colitis.

      REFERENCES
       

      1. RINVOQ Product Information.
      2. RINVOQ Consumer Medicine Information.

      I want to receive more information about RINVOQ

      Contact AbbVie

      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-ABBV-220273. August 2023