Immunology:
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      INITIATION GUIDE
      PRODUCT INFORMATION
      PATIENT BOOKLET

      DOSING IN CROHN'S DISEASE

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      INDUCTION

      Induction
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      The recommended induction dose of RINVOQ is 45 mg once daily for 12 weeks.

      MAINTENANCE

      Maintenance

      The recommended maintenance dose of RINVOQ is 15 mg or 30 mg once daily based on individual patient presentation:

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      A dose of 30 mg once daily may be appropriate for patients with high disease burden or those who do not show adequate therapeutic benefit with 15 mg once daily.

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      A dose of 30 mg once daily is recommended for patients who have not achieved adequate therapeutic benefit after the initial 12-week induction. For these patients, RINVOQ should be discontinued if there is no evidence of therapeutic benefit after 24 weeks of treatment.

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      The lowest effective dose for maintenance should be used.

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

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      In patients who are responding to induction or maintenance treatment with RINVOQ, corticosteroids may be reduced and/or discontinued in accordance with standard of care.

      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

      Missed dose: If >10 hours from the next scheduled dose, take as soon as possible, then take the next dose as usual. If <10 hours from the next scheduled dose, skip the missed dose and take the next scheduled dose the following day. Advise the patient not to double a dose to make up for a missed dose.

      Full information about RINVOQ’s dosing information in CD 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.

       

      CONTRAINDICATIONS

      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

      PAEDIATRIC POPULATION

      • 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.

      ELDERLY POPULATION

      • 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.

      HEPATIC IMPAIRMENT

      • 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).

      PREGNANCY & BREASTFEEDING

      • RINVOQ should not be used during pregnancy (category D) or during breastfeeding.

      LABORATORY MEASURES

      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.

      VACCINATION

      • Use of live, attenuated vaccines during, or immediately prior to, RINVOQ therapy is not recommended.
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      Please consult the product information for further details regarding
      contraindications, monitoring requirements and additional prescribing information
      prior to initiating RINVOQ

      RINVOQ Product Information
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      CD, Crohn’s disease; CYP3A4: cytochrome P3A4; eGFR, estimated glomerular filtration rate.

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      REFERENCES

      1. RINVOQ Product Information.
      2. RINVOQ Consumer Medicine Information.
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      I want to receive more information about RINVOQ

      Contact AbbVie
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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-240037. April 2024