Ulcerative Colitis safety guidance

In Adults

Inflectra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.¹ 

In Paediatrics

Inflectra is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.¹

Post-marketing safety

Post-marketing data of 4,393 patients has illustrated that the safety profile appears consistent with clinical studies for CT-P13 and reference infliximab, supporting the favourable risk/benefit balance for CT-P13 treatment.²

​​​​​​​Please see the link for Inflectra® (infliximab) Prescribing Information at the top of the page, and refer to Section 4.8 for a summary of the safety profile.