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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
Practical Considerations

The below information is not exhaustive. For a comprehensive list of considerations, please refer to the approved Product Information.

Laboratory monitoring recommendations for patients taking XELJANZ®

  • Dose adjustment or interruption is recommended for management of lymphopenia, neutropenia, and anaemia. If lymphocyte count or absolute neutrophil count is <0.5 x 109 cells/L, XELJANZ should be discontinued1

  • Treatment with XELJANZ should be interrupted in patients who develop Hb levels <80 g/L or those whose Hb levels drop >20 g/L on treatment1

Avoid initiation of XELJANZ treatment in patients with​​​​​​​1:

 

  • The recommended total daily dose in patients with severe renal impairment or moderate hepatic impairment is half the total daily dose recommended for patients with normal renal or hepatic function1:
    • When the indicated dose in patients with normal renal or hepatic function is XELJANZ 10 mg BID, dose should be reduced to XELJANZ 5 mg BID in patients with severe renal impairment or moderate hepatic impairment1
    • When the indicated dose in patients with normal renal and hepatic function is XELJANZ  5 mg BID, dose should be reduced to XELJANZ 5 mg once daily in patients with severe renal impairment or moderate hepatic impairment1
  • Coadministration of potent inducers of CYP3A4 with XELJANZ is not recommended1
  • Use of XELJANZ in patients with severe hepatic impairment is not recommended1
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 Approved Product Information

▼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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