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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)Tursi Study (Italy)
Supporting ResourcesSupporting ResourcesMaterialsGRAPPA GuidelinesVideosExpert Opinions

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 Psoriatic Arthritis (PsA)XELJANZ 5 mg film-coated tablets twice daily and 11 mg prolonged release once daily are the only approved dosages for the treatment of Psoriatic Arthritis (PsA).1,2Steady-state AUC and Cmax of XELJANZ for 11 mg prolonged-release tablet administered once daily are equivalent to those of 5 mg film-coated tablets administered twice daily.1-3An alternative way to treat patients with PsA1,2

Always refer to full SmPC before prescribing XELJANZ.

image

Tablets shown in the above image are not true to size.

  • XELJANZ 5 mg film-coated or 11mg prolonged release tablets can be given with or without food.
  • For patients who have difficulties swallowing, XELJANZ 5 mg tablets may be crushed and taken with water. Whereas, XELJANZ 11 mg tablet 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 is required when used in combination with MTX.
  • XELJANZ treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
  • Rapid absorption in healthy human subjects with plasma concentrations peaking approximately 1 hour after administration of 5 mg tablets. Following oral administration of tofacitinib 11 mg tablet, peak plasma concentrations are reached at 4 hours.
  • Terminal half-life of approximately 3 hours for XELJANZ 5 mg tablets and approximately 6 hours for XELJANZ 11 mg tablet.
  • XELJANZ 5 mg tablets is available in a 28-day treatment pack.
  • XELJANZ 11 mg tablets is available in HDPE (High Density Polyethylene) bottles with 2 silica gel desiccants and child-resistant, polypropylene closure containing 30 or 90 prolonged-release tablets. Or availble as aluminium foil/PVC backed aluminium foil blisters containing 7 prolonged-release tablets. Each pack contains 28 or 91 prolonged-release tablets.
imageContraindications and special populations1,2Contraindications for use
  • Hypersensitivity to the active substance of XELJANZ or to any of its excipients*
  • Active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections
  • Severe hepatic impairment
  • Pregnancy and lactation
*XELJANZ 5 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.XELJANZ 11mg contains sorbitol. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.Special populations

XELJANZ 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))
Renal impairment
  • XELJANZ dose should be reduced to 5 mg once-daily in patients with severe renal impairment (creatinine clearance <30 mL/min).
  • For severe renal impairment (including patients undergoing haemodialysis) (creatinine clearance < 30 mL/min), XELJANZ dose should be reduced to 5 mg film-coated tablet once daily when the indicated dose in the presence of normal renal function is 11 mg prolonged-release tablet once daily
  • 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).
  • For moderate hepatic impairment, XELJANZ dose should be reduced to 5 mg film-coated tablets once daily when the indicated dose in the presence of normal hepatic function is 11 mg prolonged-release tablet once daily
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.
  • Considering the increased risk of serious infections in patients 65 years of age and older, XELJANZ should only be used in these patients if no 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 (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.
Supporting Resources

Explore the resources avaliable for patients who have been prescribed XELJANZ for PsA

View ResourcesLoading

XELJANZ dose should be reduced to 5 mg once daily in patients receiving 11 mg once daily.

Note, the licensed dose of XELJANZ for the treatment of PsA in the UK is 5mg administered twice daily or one 11 mg prolonged-release tablet administered once daily, which should not be exceeded.

AUC - area under curve; Cmax - maximum concentration; MTX - methotrexate; TB - tuberculosis; RA - rheumatoid arthritis; PsA - psoriatic arthritis; OD - once daily

References

XELJANZ (tofacitinib citrate) 5 mg film-coated tablets - Summary of Product Characteristics.XELJANZ (tofacitinib citrate) 11 mg prolonged release tablet - Summary of Product Chracteristics.Lamba M, et al. J Clin Pharmacol. 2016;56(11):1362-1371.
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-4485. April 2023
Dosing in PsA

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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