Infliximab (Rheumatology)

Rheumatoid arthritis: clinical response is usually achieved within 12 weeks; for inadequate or lost response after this period either increase step-wise by approximately 1.5 mg/kg (maximum 7.5 mg/kg) every 8 weeks, or alternatively consider 3 mg/kg as often as every 4 weeks. Reconsider continued therapy carefully in patients showing no therapeutic benefit within the first 12 weeks or after dose adjustment. Ankylosing spondylitis: if a patient does not respond by 6 weeks (after 2 doses), no additional infliximab should be given. Re-administration for rheumatoid arthritis: 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 schedule. 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. Shortened infusions across adult indications: 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 not less than 1 hour; shortened infusions at doses above 6 mg/kg body weight have not been studied. Elderly: no dose adjustment required. During treatment, other concomitant therapies such as corticosteroids and immunosuppressants should be optimised. Paediatric: safety and efficacy in children and adolescents under 18 years for juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile rheumatoid arthritis have not been established and no posology recommendation can be made. (For the non-rheumatological paediatric indications in the same SPC, Crohn's disease and ulcerative colitis aged 6 to 17 years use 5 mg/kg at 0, 2 and 6 weeks then every 8 weeks.) Verify paediatric dosing against a children's formulary. SPC section 4.5 was not retrieved in this bundle; the interactions listed below are from the US label section 7 unless stated otherwise.