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 active ulcerative colitis (UC) or Crohn’s disease (CD) is 100 mg subcutaneous (SC) every 8 weeks or 200 mg SC every 4 weeks.¹
• The QUASAR registrational clinical trial program of TREMFYA 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.
• The GALAXI and GRAVITI registrational clinical trial programs of TREMFYA in adults with moderately to severely active CD 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 or CD.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 20 March 2025.