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Xeljanz® Safety Profile in UC

  

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

  

Adverse reactions   

  • 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 UC
     

  • 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)
     

  • 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.

   

Malignancies

  • No cases of cancer other than NMSC were observed with XELJANZ® (tofacitinib citrate) in the controlled UC clinical trials
     

    • 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 patient
     

  • In the open-label study, there were 9 (non-NMSC) malignancies
     

    • 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

BID, twice daily; GI, gastrointestinal; JAK, Janus kinase; NMSC, non-melanoma skin cancer; PsA, psoriatic arthritis; RA, rheumatoid arthritis; UC, ulcerative colitis.

​​​​​​​
References:

Refernces:

Sandborn WJ, Su C, Sands BE, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723-1736.Xeljanz. Local product document. Pfizer; 2022. Version LPDTOFA012022. Data on file. Pfizer Inc., New York, NY.

  

Please click the Prescribing Information link to view the safety and adverse events information of Xeljanz®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.


PP-XEL-IND-0843 22/07/22

Safety and Tolerability

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XELJANZ® (tofacitinib citrate) is a small molecule that selectively targets the JAK pathway

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Dosing & Administration

   

Helps protect against RA, PsA and UC

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These pages are not intended for patients or for members of the general public. The web pages contain promotional content. For the use only of Registered Medical Practitioners or a Hospital or a Laboratory. Full prescribing information available on request. For more details on, Who is a Registered Medical Practitioner, please visit "https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf", Page No. 39, Rule 2 part (ee), last accessed on 26th April2021.
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