Blinatumomab

SOURCE: no UK SPC (eMC) was present in this bundle — providers.emc is null — so all figures above are from the US BLINCYTO prescribing information and must be verified against the UK SPC before use. Course structure: MRD-positive disease — 1 induction cycle followed by up to 3 consolidation cycles; relapsed or refractory disease — up to 2 induction cycles, then 3 consolidation cycles and up to 4 continued-therapy cycles. INCOMPLETE: the label also carries a third indication, 'B-cell Precursor ALL in the Consolidation Phase' (section 2.3), whose dose-and-schedule table was truncated at the source-fetch limit and is NOT covered by the regimens above. Hospitalisation is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle in relapsed or refractory disease, and for the first 3 days of the first cycle and the first 2 days of the second cycle in MRD-positive disease and in the consolidation phase; for all subsequent cycle starts and re-initiations (for example if treatment is interrupted for 4 or more hours) supervision by a healthcare professional or hospitalisation is recommended. Premedication: dexamethasone for relapsed or refractory disease and for the consolidation phase; for MRD-positive disease, adults receive prednisone 100 mg intravenously or equivalent (e.g. dexamethasone 16 mg) 1 hour prior to the first dose of blinatumomab in each cycle. Intrathecal chemotherapy prophylaxis is recommended before and during therapy to prevent central nervous system ALL relapse. Administration: infusion bags may be prepared for 24 hours or 48 hours; 72-hour, 96-hour and 7-day infusions require Bacteriostatic 0.9% Sodium Chloride Injection (containing 0.9% benzyl alcohol) and are not recommended for patients weighing less than 5.4 kg. PAEDIATRIC: dosing in patients weighing less than 45 kg is body-surface-area based (micrograms/m2/day), not per kilogram, so no structured paediatric per-kg dose is recorded; safety and efficacy have not been established in patients less than 1 month of age. Paediatric premedication for MRD-positive disease is dexamethasone 5 mg/m2 intravenously or orally, to a maximum dose of 20 mg, prior to the first dose in the first cycle and when restarting an infusion after an interruption of 4 or more hours in the first cycle. Verify paediatric dosing against a children's formulary.