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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
Safety data in study JIA-I, including ORAL Surveillance summary
  • XELJANZ 5 mg tablets and XELJANZ Oral Solution were studied in 225 patients from 2 to <18 years of age in Study JIA-I, dosed according to study protocol*1,2
  • In Study JIA-I, adverse reactions included infections (upper respiratory tract infections, influenza, pharyngitis, sinusitis, viral infection) and gastrointestinal disorders or general disorders (abdominal pain, nausea, vomiting, pyrexia, headache, cough). 1,2
  • Serious infections in XELJANZ patients in Study JIA-I included appendicitis, epidural empyema (with sinusitis and subperiosteal abscess), pilonidal cyst, pneumonia, escherichia pyelonephritis, limb abscess, and UTI1,2
  • There were no cases of other AESIs (opportunistic infections, tuberculosis, malignancy [including NMSC], MACE, GI perforation, ILD, macrophage activation syndrome, thrombotic events [DVT, PE, or ATE], death)1,2
Adverse events from study JIA-I1,2*Patients received XELJANZ 5 mg BD or body weight-based equivalent of XELJANZ Oral Solution BD. Oral solution was used for patients weighing <40 kg.1
†Adjudicated events.2
‡Both nonserious.2
^One SAE of pilonidal cyst repair was coded to surgical procedures instead of infections and was inadvertently not identified as a serious infection. Following adjudication, the SAE did not meet opportunistic infection criteria; it is also included in the table as a serious infection.2
*The recommended dose of XELJANZ for RA is 5 mg BD;1†Adjudicated events.​​​​​​​XELJANZ has an integrated safety analysis from 21 RA trials (phase I–IV and open-label LTE studies), including >7000 patients and over 22,000 patient years (all XELJANZ doses)3Explore more Learn about the oral administration of XELJANZ See recommended dosing
AE=adverse event; AS=ankylosing spondylitis; ASAS=Assessment of SpondyloArthritis international Society; ATE=arterial thromboembolism; BID=twice daily; CV=cardiovascular; DVT=deep vein thrombosis; GI=gastrointestinal; ILD=interstitial lung disease; JAKi=Janus kinase inhibitor; JIA=juvenile idiopathic arthritis; MACE=major adverse cardiovascular event; MTX=methotrexate; NMSC=nonmelanoma skin cancer; PE=pulmonary embolism; PsA=psoriatic arthritis; RA=rheumatoid arthritis; SAE=serious adverse event; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis; UTI=urinary tract infection.References:XELJANZ (tofacitinib citrate) Approved Product Information.Ruperto N, et al. Lancet. 2021;398(10315):1984 -96.Cohen SB, et al. RMD Open. 2020;6(3):e001395.
Safety and Tolerability
EFFICACY

Curious about XELJANZ efficacy in JIA? 

 See JIA data
EXPERIENCE

Find out more about the JAKi with the longest market experience in RA, PsA, UC, AS and JIA

 See XELJANZ Experience

▼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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