XELJANZ® (tofacitinib citrate)| Safety Profile Summary

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Efficacy and Safety

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Safety Profile Summary

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XELJANZ Mechanism of Action

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Safety Profile Summary

Contraindications

Hypersensitivity to the active substance or to any of the excipients (see section 6.1 of the XELJANZ Summary of Product Characteristics).
Active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections (see section 4.4 of the XELJANZ Summary of Product Characteristics).
Severe hepatic impairment (see section 4.2 of the XELJANZ Summary of Product Characteristics).
Pregnancy and lactation (see section 4.6 of the XELJANZ Summary of Product Characteristics).

Undesirable Effects

Rheumatoid arthritis (RA)

The most common serious adverse reactions were serious infections (see section 4.4 of the XELJANZ Summary of Product Characteristics). In the long-term safety all exposure population, the most common serious infections reported with tofacitinib were pneumonia (1.7%), herpes zoster (0.6%), urinary tract infection (0.4%), cellulitis (0.4%), diverticulitis (0.3%), and appendicitis (0.2%). Among opportunistic infections, TB and other mycobacterial infections, cryptococcus, histoplasmosis, oesophageal candidiasis, multidermatomal herpes zoster, cytomegalovirus, BK virus infections and listeriosis were reported with tofacitinib. Some patients have presented with disseminated rather than localised disease. Other serious infections that were not reported in clinical studies may also occur (e.g., coccidioidomycosis).

The most commonly reported adverse reactions during the first 3 months of the double-blind, placebo or MTX controlled clinical trials were headache (3.9%), upper respiratory tract infections (3.8%), viral upper respiratory tract infection (3.3%), diarrhoea (2.9%), nausea (2.7%), and hypertension (2.2%).

The proportion of patients who discontinued treatment due to adverse reactions during first 3 months of the double-blind, placebo or MTX controlled studies was 3.8% for patients taking tofacitinib. The most common infections resulting in discontinuation of therapy during the first 3 months in controlled clinical trials were herpes zoster (0.19%) and pneumonia (0.15%).

Psoriatic arthritis (PsA)

Overall, the safety profile observed in patients with active PsA treated with tofacitinib was consistent with the safety profile observed in patients with RA treated with tofacitinib.

Ulcerative colitis (UC)

The most commonly reported adverse reactions in patients receiving tofacitinib 10 mg twice daily in the induction studies were headache, nasopharyngitis, nausea, and arthralgia.

In the induction and maintenance studies, across tofacitinib and placebo treatment groups, the most common categories of serious adverse reactions were gastrointestinal disorders and infections, and the most common serious adverse reaction was worsening of UC.

Overall, the safety profile observed in patients with UC treated with tofacitinib was consistent with the safety profile of tofacitinib in the RA indication.

Tabulated list of adverse reactions

The adverse reactions listed in the table below are from clinical studies in patients with RA, PsA, AS and UC and are presented by System Organ Class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

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Please refer to the XELJANZ Summary of Product Characteristics for further detail on adverse events and full prescribing information.

TNF = tumour necrosis factor; RA = rheumatoid arthritis; PsA = psoriatic arthritis; UC = ulcerative colitis; ULN = upper limit of normal; MTX = methotrexate

Reference:

XELJANZ Summary of Product Characteristics.

Safety and Tolerability

EFFICACY

Want to learn more about efficacy in RA?

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MECHANISM OF ACTION

Find out more about how XELJANZ works

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Legal Category: S1A
Further information is available upon request

PP-XEL-IRL-0933. March 2024

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

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PP-UNP-IRL-0733. March 2024