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AboutAboutHow XELJANZ worksXELJANZ in ActionCytokinesSignalling PathwaysDosingDosingDosing in RADosing in UCDosing in PsADosing in pJIA and jPsADosing in ASSpecial Warnings & PrecautionsEfficacy & SafetyEfficacy & SafetySafety & TolerabilityOral SurveillanceAdverse EventsClinical Efficacy RAORAL Strategy Study DesignORAL Strategy Efficacy ResultsORAL Strategy Safety OutcomesClinical Efficacy UCOCTAVE Study DesignOCTAVE Sub GroupsOCTAVE InductionOCTAVE SustainPost-hoc AnalysesClinical Efficacy PsAOPAL Broaden & BeyondClinical Efficacy pJIA and jPsAJIA-1 Study DesignJIA-1 Efficacy ResultsJIA-1 Safety OutcomesClinical Efficacy ASASAS20/40 DataASDAS(CRP) DataReal World EvidenceReal World EvidenceReal World Evidence
Why Real-World Data?Key Characteristics of RCTs & RWEKey Strengths & Limitations
STAR-RAMalignancy Study DesignMalignancy Risk OutcomesCV Risk Study DesignCV Risk OutcomesSCQM-RAStudy DesignStudy OutcomesCorEvitas RASafety Study DesignEfficacy Study DesignOutcomesUC RWETOUR Registry (US)Honap Study (UK)
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XELJANZ® (tofacitinib citrate) Prescribing Information and Maxtrex (methotrexate) Prescribing Information. Adverse event reporting can be found at the bottom of the page.
 
 Tofacitinib should only be used if no suitable treatment alternatives are available in patients:

  • 65 years of age and older;
  • patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
  • patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

 These risks are considered class effects and relevant across all approved indications of JAKi in inflammatory and dermatologic diseases.

XELJANZ (tofacitinib citrate) dosing in Ankylosing Spondylitis (AS)XELJANZ 5mg BID and 11mg OD are the licensed dosages for the treatment of AS. A treatment option for Ankylosing Spondylitis (AS) patients1

Always refer to the full Summary of Product Characteristics before prescribing XELJANZ.

Tablets shown not true to size.
​​​​​​​Note: the dose should not be exceeded

  • Can be given with or without food.
  • XELJANZ 5mg tablets may be crushed and taken with water for patients who have difficulties swallowing.
  • XELJANZ prolonged-release 11mg OD is pharmacokinetically equivalent to XELJANZ 5mg BID
  • XELJANZ 11 mg prolonged release tablets must be taken whole in order to ensure the entire dose is delivered correctly. They must not be crushed, split or chewed
  • No dose adjustment required when used in combination with MTX.
  • XELJANZ treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
  • Terminal half-life of approximately 3 hours for XELJANZ 5mg tablets 
  • Terminal half-life of approximately 6 hours for XELJANZ 11mg tablets
  • XELJANZ is available in a 28-day treatment pack.
  • XELJANZ 5mg tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Packs and tablets 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 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 65 years of age and older 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 the elderly. In patients 65 years of age and older XELJANZ should only be considered if no suitable alternative treatment is available.
OtherXELJANZ should only be used if no suitable treatment alternatives are available in patients:
  • 65 years of age and older;
  • patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (e.g. current or past long-term smokers);
  • patients with malignancy risk factors (e.g. current malignancy or history of malignancy (other than a successfully treated non-melanoma skin cancer))
Drug-drug interactions
  • XELJANZ dose should be reduced to 5 mg once daily in patients receiving potent inhibitors of CYP3A4 (e.g., 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 (e.g. fluconazole).
  • Co-administration of XELJANZ with potent CYP inducers (e.g. 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 JAK Selectivity in RA

Watch Professor Ernest Choy's lecture on understanding the clinical significance of JAK selectivity in RA

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* XELJANZ 5mg tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

MTX - methotrexate; BID - twice daily; OD - once daily; TB - tuberculosis; AS - Ankylosing Spondylitis.

References:XELJANZ (tofacitinib citrate) Summary of Product Characteristics.
XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.
PP-XEL-GBR-4486. March 2023
Dosing in AS

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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