This site contains promotional information intended only for healthcare professionals resident in the United Kingdom
Menu
Close
Example of description text sitting alongside header
Example of description text sitting alongside header
Menu
Close
Example of description text sitting alongside header
Example of description text sitting alongside header
Menu
Close
Adverse event reporting can be found at the bottom of the page
Menu
Close
XELJANZ® (tofacitinib citrate) Prescribing Information and Maxtrex (methotrexate) Prescribing Information. Adverse event reporting can be found at the bottom of the page.
Tofacitinib should only be used if no suitable treatment alternatives are available in patients:
These risks are considered class effects and relevant across all approved indications of JAKi in inflammatory and dermatologic diseases.
The safety profile for XELJANZ was studied across 3 large placebo-controlled Phase III clinical trials (2 induction and 1 maintenance) that included 1,139 patients with moderate to severe UC, and an open-label safety and tolerability study1,2
XELJANZ should only be used if no suitable treatment alternatives are available in patients1:
In the induction and maintenance studies, the most common types of serious adverse reactions were gastrointestinal disorders and infections, and the most common serious adverse reaction was worsening of UC1
*The rates of the 4 most frequent adverse events occurring in the maintenance trial are listed for the 3 placebo-controlled trials, and the rates of the 5 most frequently reported treatment-related adverse events are reported for the open-label extension study2,3
*The rates of the 4 most frequent adverse events occurring in the maintenance trial are listed for the 3 placebo-controlled trials, and the rates of the 5 most frequently reported treatment-related adverse events are reported for the open-label extension study2,3
*Predominant dose in the overall cohort (including patients in Phases II, III, and OLE studies) as of May 20195
In the long-term extension study, malignancies (including solid cancers, lymphomas, and NMSC) were observed more often in patients treated with XELJANZ 10 mg BID1
*Pt-yr is defined as the total follow-up time calculated up to the day of the first event4
† Includes UC patients with an average total daily dose ≥15 mg over the course of the observation. N=923 for opportunistic infection, tuberculosis, malignancy (excluding NMSC), NMSC, MACE, and gastrointestinal perforation with XELJANZ 10 mg BID PD in UC2,4
‡Includes UC patients with an average total daily dose <15 mg over the course of the observation2
§Adjudicated events4
¶Excludes tuberculosis and herpes zoster with 2 adjacent dermatomes4
#The definition of gastrointestinal perforation excludes MedDRA preferred terms of pilonidal cyst, perirectal abscess, rectal abscess, anal abscess, perineal abscess, and any preferred terms containing the term fistula2
References:
1. XELJANZ (tofacitinib citrate) Summary of Product Characteristics.
2. Sandborn WJ et al. Aliment Pharmacol Ther. 2022; 55(4): 464–478.
3. Sandborn WJ et al. N Engl J Med. 2017; 376(18): 1723 –1736.
4. Data on file. Pfizer Inc., New York, NY.
5. Winthrop KL et al. J Crohns Colitis. 2020;15(6):914–929.
6. Burmester GR et al. RMD Open. 2021; 7: e001595.
Stay up to date with the latest relevant healthcare, medical and promotional information about medicines and vaccines promoted by Pfizer.
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
This site is intended only for healthcare professionals resident in the United Kingdom. If you are a member of the public wishing to access information on a specific medicine, please visit www.medicines.org.uk/emc
This website is brought to you by Pfizer Limited, a company registered in England
and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent, CT13 9NJ
Copyright © 2024 Pfizer Limited. All rights reserved.
VAT registration number GB201048427
These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.
I confirm that I am a healthcare professional* resident in the United Kingdom.
If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.
*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.
PP-UNP-GBR-7812. January 2024