This site is intended only for healthcare professionals resident in India

Search

Menu

Close

Sign InLog Out
Our medicinesTherapy areasExplore ContentExplore contentMaterialsVideosLet's connectLet's ConnectPfizer medical information
AboutDosing & AdministrationDosing & AdministrationDosing in RADosing in PsADosing in UCPractical Considerations

Menu

Close

Efficacy & SafetyClinical Efficacy RARapid Data (ACR20)Head-to-Head Noninferiority Data (ACR50)Biologics DataClinical Efficacy PsAACR20 DataPASI75 DataEnthesitis and Dactylitis DataClinical Efficacy UC8-week EfficacyOnset of Action Data52-week EfficacyOCTAVE Study DesignSafety and TolerabilitySafety in RASafety in PsASafety in UCResources & SupportResources & SupportMaterialsVideosSummary of Prescribing Information

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:
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

About

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

Learn more

Dosing & Administration

   

Helps protect against RA, PsA and UC

Learn more

Resources & Support

Review the upcoming events

Learn more
PfizerPro AccountPfizerPro Account

To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.

Sign in or RegisterSign inRegisterAccountSign Out
 
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.
​​​​​​​
Address: The Capital,  A Wing, 1802, 18th Floor, Plot No. C-70, ‘G’ Block, Bandra Kurla Complex, Bandra East, Mumbai – 400051, India.
 
PP-XEL-IND-0843

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.

Heading

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.

ButtonButton

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Hac habitasse platea dictumst quisque sagittis purus sit amet volutpat. Lectus magna fringilla urna porttitor rhoncus. Venenatis urna cursus eget nunc scelerisque viverra. Id donec ultrices tincidunt arcu non sodales.

Sagittis aliquam malesuada bibendum arcu vitae elementum curabitur. Pellentesque elit ullamcorper dignissim cras tincidunt. Orci ac auctor augue mauris augue neque. Dui vivamus arcu felis bibendum ut tristique et egestas quis. Sed vulputate mi sit amet mauris commodo.

Nunc eget lorem dolor sed viverra ipsum. Sed ullamcorper morbi tincidunt ornare.

 
Copyright © 2022 Pfizer Limited, India. All rights reserved. Applicable for Pfizer Products, Product Microsites and Therapy Areas section of the website:
  • All content published herein is intended and strictly only for informational, educational, academic and/or research purposes and shall not be utilized to diagnose or treat a health problem or disease without referring to the full prescribing information for list of approved indications as contained in the product package insert
  • ​​​​​​​While due care and caution has been taken to ensure that the content herein is free from mistakes or omissions, Pfizer makes no claims, promises or guarantees about the accuracy, completeness or adequacy of the information herein
 
For the use of Registered Medical Practitioners only*

These pages are not intended for patients or for members of the general public. The web pages contain promotional content.


If you select 'No', you will be redirected to Pfizer.co.in

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 13th September 2019.
​​​​​​​Address: The Capital, A Wing, 1802, 18th Floor, Plot No. C-70, 'G' Block, Bandra Kurla Complex, Bandra East, Mumbai - 400051.


PP-UNP-IND-0012 July 2022
Yes No
You are now leaving PfizerPro website
​​​​​​​ ​
​​​​​You are now leaving Pfizer Pro website and will be redirected to another website. Note that you will be governed by the Terms & Conditions and Privacy Policy of the external website. Would you like to continue?

PP-UNP-IND-0012 July 2022


​​​​​​​