Siltuximab

Must be administered by qualified healthcare professionals under appropriate medical supervision. Dose reduction is NOT recommended. Haematology laboratory tests should be performed prior to each dose for the first 12 months and every third dosing cycle thereafter; consider delaying treatment if the treatment criteria are not met. Criteria before the first administration: absolute neutrophil count >= 1.0 x 10^9/L, platelet count >= 75 x 10^9/L, haemoglobin < 170 g/L (10.6 mmol/L). Retreatment criteria: absolute neutrophil count >= 1.0 x 10^9/L, platelet count >= 50 x 10^9/L, haemoglobin < 170 g/L (siltuximab may increase haemoglobin levels in MCD patients). Withhold therapy if the patient has a severe infection or any severe non-haematological toxicity; it can be restarted at the same dose after recovery. Discontinue further administration permanently if the patient develops a severe infusion related reaction, anaphylaxis, severe allergic reaction, or cytokine release syndrome related to the infusion. Consider discontinuing if there are more than 2 dose delays due to treatment-related toxicities during the first 48 weeks. Infections, including localised infections, should be treated prior to administration. Live, attenuated vaccines should not be given concurrently or within 4 weeks before initiating siltuximab. Elderly: no dose adjustment required. Paediatric: the safety and efficacy of siltuximab in children aged 17 years and younger have not been established; no data are available. Note: eMC section 4.5 (interactions) was not present in the fetched bundle, so no interaction list is given here — clinician to source.