SUMMARY

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to the local labeling for relevant information regarding the use of TREMFYA in adult patients with Crohn’s disease or ulcerative colitis with a history of malignancy.
• TREMFYA has not been studied in adult patients with moderately to severely active Crohn’s disease or ulcerative colitis with a history of malignancy within 5 years before screening with the exception of adequately treated nonmelanoma skin cancer or cervical carcinoma in situ. Patients with malignancy were excluded in GALAXI and GRAVITI trials for Crohn’s disease and ASTRO and QUASAR trials for ulcerative colitis.^1-4 

CLINICAL PROTOCOLS FOR CROHN’S DISEASE and ULCERATIVE COLITIS

Exclusion Criteria

Malignancy or Increased Potential for Malignancy

• Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months [defined as a minimum of 12 weeks] before the first study intervention administration or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 3 months before the first study intervention administration).^1-4 
• Has a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy, hepatomegaly, or splenomegaly, or monoclonal gammopathy of undetermined significance.^1-4 

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 01 December 2025.