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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 & LimitationsSTAR-RAMalignancy Study DesignMalignancy Risk OutcomesCV Risk Study DesignCV Risk OutcomesSCQM-RAStudy DesignStudy OutcomesCorEvitas RASafety Study DesignEfficacy Study DesignOutcomesUC RWETOUR Registry (US)Honap Study (UK)Supporting ResourcesSupporting ResourcesMaterialsVideosGRAPPA GuidelinesExpert 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 pJIA and jPsAXELJANZ has 2 oral formulations available for active polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPSA): tablets and grape-flavoured oral solution.1,2

Always refer to full SmPC before prescribing XELJANZ.

Not actual size.

The availability of both tablets and oral solution allows you to adapt treatment, helping patients with active pJIA and jPsA stay on treatment.

In a palatability survey conducted on Day 14 of the open-label phase, of those surveyed (n/N=66/85) 78% liked the taste of XELJANZ Oral Solution*3
3

*Based on a palatability survey that involved 85 patients receiving XELJANZ Oral Solution at 5 mg BID or equivalent weight-based lower dose. At Week 2 of the open-label phase, taste acceptability was assessed by having either the patient, the patient’s parent or guardian, or the study site staff record the patient’s reaction to the oral solution taste. One of 5 categories that most adequately reflected the patient’s response to the taste of the oral solution was selected. Age-appropriate tools (using wording and/or graphic facial expressions) were used to assess taste acceptability. Those surveyed selected from the following categories using a Likert scale: 34 patients liked ‘very much’ (40%), 32 liked ‘a little’ (38%), 6 were ‘not sure’ (7%), 8 disliked ‘a little’ (9%), and 4 disliked ‘very much’ (5%).3

Recommended dosage of XELJANZ/XELJANZ Oral Solution in patients with pJIA and jPsA 1,4
Scroll left to view table

Xeljanz Tablets/ Xeljanz Oral Solution

Patients with pJIA and jPsA

Body weight
10–<20 kg

3.2 mg (3.2 mL
oral solution) BID

Body weight
20–<40 kg

4 mg (4 mL
oral solution) BID

Body weight 
≥40 kg

5 mg (one 5 mg tablet or 5 mL oral solution*) BID

Patients receiving:

• Strong CYP3A4 inhibitors (e.g. ketoconazole), or

• A moderate CYP3A4 inhibitor(s) with a strong CYP2C19
inhibitor(s) (e.g. fluconazole)

If taking 3.2 mg BID, reduce to 3.2 mg OD

If taking 4 mg BID, reduce to 4 mg OD

If taking 5 mg BID, reduce to 5 mg OD

Patients with:

• Severe renal impairment (<30mL/min or haemodialysis)

• Moderate hepatic impairment (Child Pugh B)



Dose should be reduced to 5 mg or weight-based equivalent once daily when the indicated dose in the presence of normal renal or hepatic function is 5 mg or weight-based equivalent twice daily

Patients with severe renal impairment should remain on a reduced dose even after haemodialysis

Patients with severe hepatic impairment (Child Pugh C)

Use is not recommended

Patients with lymphocyte count <0.5 cells x 109/L,
confirmed by repeat testing within 7 days

Discontinue dosing

Patients with lymphocyte count 0.5–0.75 cells x 109/L

For persistent (2 sequential values in this range on routine testing) decrease in this range, dosing should be reduced or interrupted. For patients receiving tofacitinib 5 mg twice daily, dosing should be interrupted

Patients with ANC 0.5–1.0 cells x 109/L

If persistent decreases in this range, interrupt dosing until ANC is >1.0 cells x 109/L

Patients with ANC <0.5 cells x 109/L

If lab value is confirmed by repeat testing within 7 days, discontinue dosing

Patients with haemoglobin less than 8 g/dL or a decrease
of more than 2 g/dL


​​​​​​Interrupt dosing until haemoglobin values have normalised

It is recommended to not initiate dosing in paediatric patients with haemoglobin less than 10 g/dL

**Patients weighing ≥40 kg treated with 5 mL XELJANZ Oral Solution may be switched to a XELJANZ 5 mg tablet. Patients weighing <40 kg cannot be switched from XELJANZ Oral Solution.1,2

Supporting Resources

Explore the resources avaliable for patients who have been prescribed XELJANZ for pJIA and jPsA.

 View Resources Loading

ANC, absolute neutrophil count; jPsA, juvenile psoriatic arthritis; pJIA, polyarticular juvenile idiopathic arthritis

​​​​​​​References

XELJANZ (tofacitinib citrate) 5 mg film-coated tablets Summary of Product CharacteristicsXELJANZ (tofacitinib citrate) 1 mg/mL Oral Solution Summary of Product Characteristics.Data on File. REF-XEL22144, Pfizer Ltd.Cohen SB, et al. Lancet Rheumatol 2019;1:23–34.
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-4488. April 2023
Dosing in pJIA and jPsA

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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