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About JAKi Experience  JAKi Market Experience XELJANZ Mechanism of Action Efficacy and Safety Clinical Efficacy RA Rapid Data (ACR20) Head-to-Head Noninferiority Data (ACR50) Clinical Efficacy PsA ACR20 Data PASI75 Data Enthesitis and Dactylitis Data Clinical Efficacy UC 8-Week Efficacy Onset of Action Data 52-Week Efficacy OCTAVE Study Design Safety and Tolerability Safety in RA Safety in PsA Safety in UC Dosing and Administration Dosing in RA Dosing Practical Considerations Dosing in PsA Dosing Practical Considerations Dosing in UC Dosing Practical Considerations Resources and Support Resources and Support eXel ProgramEventsMaterials Videos
Dosing and administration in UCOral efficacy that does not require injections or infusions​​​​​​​1
  • XELJANZ is indicated for the treatment of adult patients with moderately to severely active 
    ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant 
    to either conventional therapy or a biological therapy.1

Use the lowest effective dose of XELJANZ to maintain response.1

  • The recommended dose of XELJANZ is 10 mg BID for induction for at least 8 weeks and 5 mg BID for maintenance1
  • Induction therapy should be discontinued in patients who show no improvement in UC signs and symptoms by week 161​​​​​​​​​​​​​​
Dosage adjustments1Explore more Practical considerations for XELJANZ dosing Learn more

ALC=absolute lymphocyte count; ANC=absolute neutrophil count; BID=twice daily; eGFR=estimated glomerular fiitration rate; HDL= high-density lipoprotein; LDL= low-density lipoprotein; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis.

Dosing in UC
SAFETY

Learn more about the XELJANZ safety profile

See safety in UC
EFFICACY

Would you like to see pivotal data in moderate to severe UC?

See UC data
References:XELJANZ (tofacitinib citrate) Approved Product Information.Sandborn WJ, Su C, Sands BE, et al; for the OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723-1736.

This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

WARNINGS 
XELJANZ 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. 

See PI for details, Section 4.4 Special Warnings and Precautions for Use: Mortality; Major Adverse Cardiovascular Events (including Myocardial Infarction); Thrombosis; Malignancy and Lymphoproliferative Disorder (excluding Nonmelanoma Skin Cancer [NMSC]); Skin Cancer and Use in the Elderly. 


Before prescribing, please review full Product Information available here.
 

PBS Information: Authority required for the treatment of adults with severe active rheumatoid arthritis and for adults with severe psoriatic arthritis and for adults with moderate-to-severe ulcerative colitis. Refer to the PBS Schedule for full authority information. This product is not listed on the PBS for juvenile idiopathic arthritis, juvenile psoriatic arthritis, or ankylosing spondylitis.

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PP-XEL-AUS-1409 06/23.
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