Ustekinumab

SCOPE: this draft covers the INTRAVENOUS INDUCTION DOSE ONLY, for the page's primary indication (Crohn's disease and ulcerative colitis). The fetched UK SPC is the STELARA 130 mg concentrate for solution for infusion and states: 'STELARA concentrate for solution for infusion should only be used for the intravenous induction dose.' VERBATIM (§4.2, Adults, Crohn's Disease and Ulcerative Colitis): 'STELARA treatment is to be initiated with a single intravenous dose based on body weight.' Table 1 gives 260 mg (2 vials), 390 mg (3 vials) and 520 mg (4 vials), with the footnote 'Approximately 6 mg/kg'. TABLE TRANSCRIPTION CAVEAT: the '>' characters of the weight bands were lost in the fetched eMC text (it reads '<= 55 kg / 55 kg to <= 85 kg / 85 kg'); the identical table in the US label (Table 4) reads '55 kg or less', 'more than 55 kg to 85 kg' and 'more than 85 kg', which is how the bands are written above. SUBCUTANEOUS MAINTENANCE IS NOT IN THIS BUNDLE AND NO SUBCUTANEOUS MILLIGRAM FIGURE IS REPRODUCED HERE: §4.2 states only that the first subcutaneous dose is given at week 8 and cross-refers to §4.2 of the STELARA solution for injection (vial), pre-filled syringe or pre-filled pen SmPC — source that SmPC separately for the maintenance dose and interval. The UK source in this bundle carries no plaque psoriasis or psoriatic arthritis posology, and none is reproduced here. SPECIALIST USE: 'intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis.' ELDERLY (65 years and over): 'No dose adjustment is needed for elderly patients.' NO MAXIMUM DOSE IS STATED anywhere in the fetched sections — 520 mg is the highest weight band in Table 1, not a stated ceiling — so maxDose is left empty. TRACEABILITY (§4.4): 'the tradename and the batch number of the administered product should be clearly recorded.'

PAEDIATRIC CROHN'S DISEASE, PATIENTS WEIGHING AT LEAST 40 kg (§4.2, Table 2) — a single weight-based intravenous induction dose: at least 40 kg to 55 kg or less, 260 mg (2 x 130 mg vials); more than 55 kg to 85 kg, 390 mg (3 vials); more than 85 kg, 520 mg (4 vials); footnote 'Approximately 6 mg/kg'. (As for the adult table, the '>' characters were lost in the fetched eMC text and were resolved from the identical US label table.) dosePerKg IS DELIBERATELY NULL: this is a fixed weight-BAND regimen, not a per-kg calculation — the 'approximately 6 mg/kg' footnote describes the bands and is not a dosing instruction, so putting it in a weight calculator would generate doses that appear nowhere in the SPC. NOT ESTABLISHED (§4.2, verbatim): 'The safety and efficacy of STELARA for the treatment of Crohn's disease in paediatric patients weighing less than 40 kg or ulcerative colitis in children less than 18 years have not yet been established. No data are available.' The subsequent subcutaneous maintenance posology is in a different SmPC that is not in this bundle and no subcutaneous figure is reproduced here. Verify any under-18 use against a children's formulary and specialist paediatric IBD advice.