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TREMFYA - Alternative Maintenance Dosing for TREMFYA in Ulcerative Colitis- 100 mg SC Every 4 Weeks or 200 mg SC Every 8 Weeks

Last Updated: 11/08/2024

SUMMARY  

  • The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
  • The recommended maintenance dosage of TREMFYA for adults with moderately to severely ulcerative colitis (UC) is 100 mg subcutaneous (SC) every 8 weeks or 200 mg SC every 4 weeks.1
  • The QUASAR registrational clinical trial program of TREMAYA in adults with moderately to severely active UC did not evaluate the maintenance dosage of 100 mg SC every 4 weeks or 200 mg SC every 8 weeks; therefore, the efficacy and safety of these dosage regimens have not been determined. Please refer to the TREMFYA Prescribing Information for the recommended dosage regimen for adults with moderately to severely active UC.

Literature Search

A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 16 October 2024.

 

References

1 TREMFYA (guselkumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf