Crohn's Disease safety guidance

In Adults

Inflectra is indicated for:

• Treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.¹

• Treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).¹

In Paediatrics

Inflectra is indicated for treatment of severely active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.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.