The safety profile for XELJANZ® (tofacitinib citrate) was studied across 3 large placebo-controlled, phase 3 clinical trials (2 induction and 1 maintenance) that included 1139 patients with, moderate to severe UC, and an open-label safety and tolerability study.1,2
In the induction and maintenance studies across all treatment groups, the most common types of serious adverse reactions were GI disorders and infections, and the most common serious adverse reaction was worsening of UC2
Less than 5% of patients in any of the XELJANZ® (tofacitinib citrate) or placebo treatment groups in the induction and maintenance studies discontinued because of adverse events (excluding patients with worsening UC)3
Serious adverse events were comparably low across treatment groups in all studies1,3
No difference in cases of GI perforation between XELJANZ® (tofacitinib citrate) and placebo in the OCTAVE Induction and maintenance trials
Adapted from Sandborn WJ, et al. 2017; Data on file. Pfizer Inc.
No cases of cancer other than NMSC were observed with XELJANZ® (tofacitinib citrate) in the controlled UC clinical trials1
NMSC included 2 cases of basal cell carcinoma with 2 cases of squamous cell carcinoma, 1 case of colon adenoma and 1 case of GI tract adenoma
One case of breast cancer was reported in a placebo-treated patient1
In the open-label study, there were 9 (non-NMSC) malignancies3
Cervical dysplasia, hepatic angiosarcoma, essential thrombocythaemia, acute myeloid leukaemia, cholangiocarcinoma and leiomyosarcoma
Epstein-Barr virus–associated lymphoma, renal cell carcinoma and adenocarcinoma of the colon
NMSC included 3 cases of basal cell carcinoma and 4 cases of squamous cell carcinoma
Recommended dose is 10 mg given orally BID for induction for 8 weeks
Recommended dose for maintenance treatment is XELJANZ® (tofacitinib citrate) 5 mg given orally BID2
Please click the Prescribing Information link to view the safety and adverse events information of Xeljanz®.
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Dosing & Administration
Helps protect against RA, PsA and UC
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