Safety and Tolerability

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JAKi Experience

JAKi Market Experience

XELJANZ Mechanism of Action

Efficacy and Safety

Rapid Data (ACR20)

Clinical Efficacy PsA

OCTAVE Study Design

Safety and Tolerability

Safety in RA

Safety in PsA

Safety in UC

Safety in AS

Safety in JIA

Clinical 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

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Safety in AS, including ORAL Surveillance postmarketing data

Study AS-I: Baseline characteristics and demographics¹

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One patient did not take prior NSAIDs due to medical history.¹

Patients designated as TNFi-IR must have had an IR to at least one, but not more than two, approved TNFi.¹

Summary of adverse events in AS-I¹

No other AESIs were observed up to week 48.¹

*Serious AEs were defined as any untoward medical occurrence at any dose that was life-threatening; resulted in hospitalisation, prolongation of existing hospitalisation, persistent or significant disability/incapacity, congenital anomaly/birth defect or death; or was considered to be an important medical event.

^†Investigators used the adjectives mild, moderate or severe to describe the maximum intensity of the AE. Severe AEs were defined as those that interfered significantly with the patient’s usual function.¹

Most common AEs in AS-I¹

AEs by preferred term (>5% of any treatment group)¹

ORAL Surveillance in high-risk patients ≥50 years of age with RA with ≥ 1 CV risk factor: The prespecified non-inferiority criterion was not met for the primary comparison of the combined XELJANZ doses to TNFi for adjudicated MACE and malignancies (excluding NMSC)⁵

ORAL Surveillance was a randomised, open label, non-inferiority, post-authorisation safety study in patients with RA ≥50 years of age, with ≥1 additional CV risk factor⁵
Primary comparisons exceeded the prespecified non-inferiority criterion of 1.8 in the upper boundary of 95% CI:
- For adjudicated MACE, the hazard ratio for the combined XELJANZ doses vs. TNFi was 1.33 (95% CI: 0.91, 1.94)⁵
- For adjudicated malignancies (excluding NMSC), the hazard ratio for the combined XELJANZ doses vs. TNFi was 1.48 (95% CI: 1.04, 2.09)⁵

*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)²

Explore more

Learn about the oral administration of XELJANZ

See recommended dosing

AE=adverse event; ALT=alanine aminotransferase; AS=ankylosing spondylitis; ASAS=Assessment of SpondyloArthritis international Society; AST=aspartate aminotransferase; ATE=arterial thromboembolism; bDMARD=biologic disease-modifying antirheumatic drug; BID=twice daily; BMI=body mass index; CRP=C-reactive protein; CV=cardiovascular; DILI=drug-induced liver injury; DVT=deep vein thrombosis; GI=gastrointestinal; hsCRP=high-sensitivity C-reactive protein; HZ=herpes zoster; ILD=interstitial lung disease; IR=inadequate response; JAKi=Janus kinase inhibitor; JIA=juvenile idiopathic arthritis; MACE=major adverse cardiovascular event; MR=modified release; MTX=methotrexate; NMSC=nonmelanoma skin cancer; NSAID=nonsteroidal anti-inflammatory drug; PE=pulmonary embolism; PsA=psoriatic arthritis; pt-yr=patient year; QD=once daily; RA=rheumatoid arthritis; RCT=randomized controlled trial; SD=standard deviation; TB=tuberculosis; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis; ULN=upper limit of normal; URTI=upper respiratory tract infection; VTE=venous thromboembolism.

References:

Deodhar A, et al. Ann Rheum Dis 2021;80(8):1004–1013 (and Supplement).

Cohen SB, et al. RMD Open 2020;6(3):e001395.

Mease P, et al. Ann Rheum Dis 2020;79(11):1400–1413.

XELJANZ (tofacitinib citrate) Approved Product Information.

Ytterberg SR, et al. N Engl J Med 2022;386(4):316–326.

Safety and Tolerability

EFFICACY

Have you seen how XELJANZ performed when evaluated against ASAS20 and ASAS40 criteria?

See AS data

EXPERIENCE

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

®Registered Trademark.

PP-XEL-AUS-1428 11/23.

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