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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 Safety in ASSafety in JIAClinical Efficacy AS ASAS20/40 Data
Back Pain and Spinal Mobility Data
ASDAS(CRP) Data
Clinical Efficacy JIA
Disease Flare Data
ACR30/50/70 Data
 Dosing and Administration Dosing in RA Dosing Practical Considerations Dosing in PsA Dosing Practical Considerations Dosing in UC Dosing Practical Considerations Dosing in AS
Dosing Practical Considerations Dosing in JIA
Dosing Practical Considerations Resources and Support Resources and Support EventsMaterials Videos
Dosing and administration in AS1Tablets shown not true to size.
  • XELJANZ 5 mg can be given with or without food
  • Rapid absorption in healthy human subjects with plasma concentrations peaking within 0.5-1 hour after administration
  • Half-life of approximately 3 hours
  • XELJANZ is available in treatment packs of 14, 56, 60, or 180 film-coated tablets
Pack shown not true to size.Contraindications and special populations1Contraindications for use:
  • Hypersensitivity to the active substance of tofacitinib citrate or to any of its excipients
  • Active TB, serious infections such as sepsis, or opportunistic infections
  • Severe hepatic impairment
  • Pregnancy and lactation
Special populations:Renal impairment
  • XELJANZ dose should be reduced to 5 mg once daily in patients with renal impairment (eGFR less than or equal to 50 mL/min)
  • This is including but not limited to those with severe renal impairment who are undergoing haemodialysis
Hepatic impairment
  • XELJANZ dose should be reduced to 5 mg once daily in patients with moderate hepatic impairment (Child-Pugh B)
  • XELJANZ should not be used in patients with severe hepatic impairment (Child-Pugh C)
Elderly
  • No dose adjustment is required in patients aged ≥65 years based on age alone (see other special populations). There are limited data in patients aged 75 years and older
  • Considering the increased risk of serious infections, myocardial infarction, and malignancies with XELJANZ in patients ≥65 years of age, XELJANZ should only be used in these patients if no other suitable treatment alternatives are available
Drug-drug interactions
  • XELJANZ dose should be reduced to 5 mg once daily in patients receiving potent inhibitors of CYP3A4 (eg, ketoconazole)
  • XELJANZ dose should also be reduced to 5 mg once daily in patients receiving one or more concomitant medicines that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (eg, fluconazole)
  • Co-administration of XELJANZ with potent CYP inducers (eg, rifampicin) may result in a loss of or reduced clinical response
  • Co-administration of potent inducers of CYP3A4 with XELJANZ is not recommended
Explore more Practical considerations for XELJANZ dosing Learn more


AS=ankylosing spondylitis; TB=tuberculosis. 

Reference:XELJANZ (tofacitinib citrate) Approved Product Information.
Dosing and Administration in AS SAFETY

See the XELJANZ safety data for AS

 See safety in AS EFFICACY

Want to see pivotal data in active AS?

 See AS data

▼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. Refer to PBS Schedule for full authority information.

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PP-XEL-AUS-1429 11/23.

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