Adult dose and durationIntravenous infusion, dosed by body weight, and never given alone. SmPC verbatim: "3 mg/kg given as an intravenous infusion followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter." and "Remsima must be given concomitantly with methotrexate." Where response fades: "consideration may be given to increase the dose step-wise by approximately 1.5 mg/kg, up to a maximum of 7.5 mg/kg every 8 weeks. Alternatively, administration of 3 mg/kg as often as every 4 weeks may be considered." - Reviewed at 12 weeks. SmPC verbatim: "Available data suggest that the clinical response is usually achieved within 12 weeks of treatment." and "Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment or after dose adjustment."
Paediatric doseNot a paediatric prescription in this disease. SmPC verbatim: "The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of juvenile rheumatoid arthritis have not been established."
Dose sourceRemsima 100 mg powder for concentrate for solution for infusion (infliximab) SmPC sections 4.1, 4.2, 4.3 and 4.4 (eMC product 3709)
WhyThe disease article names it among the anti-TNF drugs, verbatim: "Anti-TNF-alpha inhibitors include etanercept, infliximab, adalimumab, golimumab, and certolizumab pegol." and places the class, verbatim: "The ACR does not recommend using TNF inhibitors until a nonbiologic DMARD has been tried." The SmPC's indication section names the disease, verbatim: Remsima "in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate." The card already carries the four non-biologic DMARDs the article names; the biologic step was not shown at all. Egypt registers one infliximab product, REMICADE 100 mg powder for intravenous infusion at roughly 5,900 EGP a vial, and a course is several vials per infusion at adult body weights.
Cautions- RED FLAG - tuberculosis is excluded before the first infusion, not after it. SmPC verbatim: "Before starting treatment with infliximab, all patients must be evaluated for both active and inactive ('latent') tuberculosis." and "Appropriate screening tests, (e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients". The SmPC also warns that "in the majority of these reports tuberculosis was extrapulmonary". Latent tuberculosis is common in Egypt, so this is a real gate rather than a formality.
- Infection risk runs for months after the last infusion. SmPC verbatim: "Patients must be monitored closely for infections including tuberculosis before, during and after treatment with infliximab. Because the elimination of infliximab may take up to six months, monitoring should be continued throughout this period. Further treatment with infliximab must not be given if a patient develops a serious infection or sepsis." A blunted fever is part of the hazard - "suppression of TNF may mask symptoms of infection such as fever".
- Contraindicated outright in some patients. SmPC verbatim: "Patients with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections" and "Patients with moderate or severe heart failure (NYHA class III/IV)".
- An intravenous hospital drug, not a prescription pad drug. SmPC verbatim: "Remsima infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues." and "Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions".
- Record the brand and batch at every infusion. SmPC verbatim: "In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded." Infliximab biosimilars are not interchangeable without a record of which was given.