- 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).
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%).
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.
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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