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

Practical Consideration1

Serious infections

   

Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral or other opportunistic pathogens have been reported in patients receiving tofacitinib. 

   

Tuberculosis

   

Patients should be evaluated and tested for latent or active infection prior to and per applicable guidelines during the administration of tofacitinib.

   

Viral reactivation

   

Viral reactivation, including cases of herpes virus reactivation (e.g. herpes zoster), was observed in clinical studies with tofacitinib.

   

Mortality

   

Patients with RA aged 50 years and older with at least 1 CV risk factor who were treated with Tofacitinib 5 mg BID or Tofacitinib 10 mg BID had a higher rate of all-cause mortality.

   

Malignancy and lymphoproliferative disorder

   

Consider the risks and benefits of tofacitinib treatment prior to initiating the therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing tofacitinib in patients who develop a malignancy. NMSCs have been reported in patients treated with tofacitinib. Periodic skin examination is recommended for patients who are at an increased risk of skin cancer.

   

Thrombosis

   

Thrombosis, including PE, deep venous thrombosis and arterial thrombosis, has occurred in patients treated with tofacitinib and other JAKis that are used to treat inflammatory conditions.

   

GI perforations

   

Events of GI have been reported in clinical studies with tofacitinib, although the role of JAKis in these events is not known.

   

Hypersensitivity

   

Reactions such as angioedema and urticaria that may reflect drug hypersensitivity have been observed in patients receiving tofacitinib.

   

Lymphocyte abnormalities

   

Treatment with tofacitinib was associated with initial lymphocytosis at 1 month of exposure followed by a gradual decrease of approximately 10% in the mean absolute lymphocyte counts below the baseline during the 12 months of therapy. Lymphocyte counts less than 500 cells/mm3 were associated with an increased incidence of treated and serious infections.

   

Neutropenia

   

Treatment with tofacitinib was associated with an increased incidence of neutropenia (less than 2000 cells/mm3) compared to placebo.

   

Anaemia

   

Avoid initiation of tofacitinib treatment in patients with a low haemoglobin level (i.e. less than 9 g/dL).

   

Liver enzyme elevations

   

Treatment with tofacitinib was associated with an increased incidence of liver enzyme elevation compared to treatment with placebo.

   

Lipid elevations

   

Treatment with tofacitinib was associated with dose-dependent increases in lipid parameters including total cholesterol, LDL cholesterol and HDL cholesterol.

   

Vaccinations

   

Avoid the use of live vaccines concurrently with tofacitinib.

   

Explore more

Practical considerations for XELJANZ® (tofacitinib citrate) dosing Learn moreLoading


CV, cardiovascular; GI, gastrointestinal; HDL, high-density lipoprotein; JAKi, Janus kinase inhibitor; LDL, low-density lipoprotein; NMSC, non-melanoma skin cancer; PE, pulmonary embolism; RA, rheumatoid arthritis; UC, ulcerative colitis.


Reference:Xeljanz. Local product document. Pfizer; 2022. Version LPDTOFA012022.


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

Dosing & Administration

About

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

Learn more

Efficacy & Safety

Efficacy proven by different studies

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


​​​​​​​