Infliximab

Source is the Flixabi 100 mg powder for concentrate for solution for infusion SPC. Treatment must be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of inflammatory bowel disease; other concomitant therapies (e.g. corticosteroids and immunosuppressants) should be optimised. MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE: 5 mg/kg IV, followed by an additional 5 mg/kg 2 weeks after the first infusion; if a patient does not respond after 2 doses, no additional infliximab should be given (available data do not support further treatment in patients not responding within 6 weeks of the initial infusion). In responders, either maintenance (additional 5 mg/kg at 6 weeks after the initial dose, then every 8 weeks) or re-administration (5 mg/kg if signs and symptoms recur). FISTULISING, ACTIVE CROHN'S DISEASE: 5 mg/kg IV followed by additional 5 mg/kg infusions at 2 and 6 weeks; if a patient does not respond after 3 doses, no additional infliximab should be given; in responders, maintenance 5 mg/kg every 8 weeks, or re-administration on recurrence followed by 5 mg/kg every 8 weeks. ULCERATIVE COLITIS: 5 mg/kg IV followed by additional 5 mg/kg doses at 2 and 6 weeks, then every 8 weeks thereafter; clinical response is usually achieved within 14 weeks (three doses) and continued therapy should be carefully reconsidered if there is no evidence of therapeutic benefit within that period; safety and efficacy of re-administration other than every 8 weeks has not been established. DOSE ESCALATION: limited data in patients who initially responded to 5 mg/kg but lost response indicate some may regain response with dose escalation; continued therapy should be carefully reconsidered if there is no evidence of benefit after dose adjustment. (For reference, the SPC's rheumatoid arthritis regimen is 3 mg/kg at 0, 2 and 6 weeks then every 8 weeks with methotrexate, with step-wise escalation by approximately 1.5 mg/kg up to a maximum of 7.5 mg/kg every 8 weeks - no equivalent numeric maximum is stated for the IBD indications.) RE-ADMINISTRATION IN CROHN'S DISEASE: infliximab can be re-administered within 16 weeks following the last infusion; safety and efficacy of re-administration after an infliximab-free interval of more than 16 weeks has not been established. If maintenance therapy is interrupted and treatment must restart, a re-induction regimen is not recommended - re-initiate as a single dose followed by the maintenance recommendations. ADMINISTRATION: observe all patients for at least 1-2 hours post-infusion for acute infusion-related reactions; emergency equipment (adrenaline, antihistamines, corticosteroids, artificial airway) must be available; patients may be pre-treated with e.g. an antihistamine, hydrocortisone and/or paracetamol and the infusion rate may be slowed to reduce the risk of infusion-related reactions. SHORTENED INFUSIONS (adults): in carefully selected adults who have tolerated at least 3 initial 2-hour infusions and are on maintenance therapy, subsequent infusions may be given over a period of not less than 1 hour; shortened infusions at doses > 6 mg/kg have not been studied. ELDERLY: no dose adjustment required.

Crohn's disease and ulcerative colitis, 6 to 17 years: 5 mg/kg bw IV followed by additional 5 mg/kg infusions at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Crohn's disease - available data do not support further treatment in children and adolescents not responding within the first 10 weeks. Ulcerative colitis - available data do not support further treatment in paediatric patients not responding within the first 8 weeks. Some patients may require a shorter dosing interval to maintain clinical benefit and others a longer one; patients whose dose interval has been shortened to less than 8 weeks may be at greater risk of adverse reactions, and continued therapy with a shortened interval should be carefully considered where there is no evidence of additional benefit. Safety and efficacy have not been studied in children with Crohn's disease or ulcerative colitis below the age of 6 years, and no posology recommendation can be made under 6 years. Verify against a children's formulary before prescribing.