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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 PsATablets shown not true to size.
  • XELJANZ 5 mg can be given with or without food
  • Swallow the tablets whole with a full glass of water.
  • Rapid absorption in healthy human subjects with plasma concentrations peaking approximately 1 hour after administration
  • ​​​​​​​Terminal half-life of approximately 3 hours
  • ​​​​​​​XELJANZ is available in a 28-day treatment pack
  • ​​​​​​​XELJANZ contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product
Pack shown not true to size.Contraindications and special populations1Contraindications for use:
  •  
  • Hypersensitivity to the active substance or to any of the excipients
  • ​​​​​​​Active tuberculosis (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 severe renal impairment (creatinine clearance <30 mL/min)​​​​​​​
  • ​​​​​​​Patients with severe renal impairment should remain on a reduced dose of 5 mg once daily even after hemodialysis
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
  • The elderly population in general has an increased risk of infections; caution should be used when treating in elderly. In patients over 65 years of age XELJANZ should only be considered if no suitable alternative treatment is 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 morePractical considerations for XELJANZ dosing Learn more MTX=methotrexate; PsA=psoriatic arthritis; TB=tuberculosis. ​Dosing and Administration in PsA
SAFETY

See the XELJANZ safety data for PsA

See safety in PsA
EFFICACY See PsA data
Reference:XELJANZ (tofacitinib citrate) 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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