Risankizumab

SCOPE: this is the page's primary indication - inflammatory bowel disease in adults - and is taken from US labelling because the UK SPC in this bundle does not cover IBD at all. VERBATIM US LABEL, Crohn's disease (section 2.6 Highlights): 'The recommended induction dosage is 600 mg administered by intravenous infusion over at least one hour at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain therapeutic response.' VERBATIM, ulcerative colitis (section 2.7 Highlights): 'The recommended induction dosage is 1,200 mg administered by intravenous infusion over at least two hours at Week 0, Week 4, and Week 8. The recommended maintenance dosage is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage to maintain therapeutic response.' BEFORE STARTING (section 2.1): 'For the treatment of moderately to severely active Crohn's disease and ulcerative colitis, obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI.' 'Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI.' 'Complete all age-appropriate vaccinations as recommended by current immunization guidelines.' PRESENTATIONS THAT DELIVER THESE DOSES (section 3): 600 mg/10 mL (60 mg/mL) single-dose vial for intravenous infusion; 180 mg/1.2 mL (150 mg/mL) and 360 mg/2.4 mL (150 mg/mL) single-dose prefilled cartridges for use with the on-body injector. DO NOT CONFUSE WITH THE PSORIASIS DOSE: the 150 mg subcutaneous regimen at Week 0, Week 4 and every 12 weeks - the only adult regimen in the UK pre-filled pen SPC - is for plaque psoriasis and psoriatic arthritis, NOT for IBD. MISSED DOSE (UK SPC 4.2, stated for the psoriasis/PsA regimens): 'If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time.' No IBD-specific missed-dose instruction was retrieved.

NO PAEDIATRIC IBD DOSE EXISTS IN EITHER FETCHED LABEL. US label section 8.4 establishes paediatric safety and effectiveness only for moderate-to-severe plaque psoriasis and for active psoriatic arthritis, in patients 6 years of age and older; it makes no paediatric statement for Crohn's disease or ulcerative colitis. UK SPC 4.2 likewise doses paediatric patients only for plaque psoriasis (from 6 to less than 18 years) and states that safety and efficacy in under-18s with psoriatic arthritis have not been established. SAFETY WARNING: the weight-banded paediatric figures that do appear in both labels - 55 mg for body weight under 40 kg and 150 mg for 40 kg or greater, subcutaneously at Week 0, Week 4 and every 12 weeks thereafter - belong to the plaque psoriasis and psoriatic arthritis indications and must NOT be applied to inflammatory bowel disease. Those figures are weight-banded, not per-kilogram, so no weight-calculator value is published here either. For any patient under 18 with IBD, seek specialist paediatric gastroenterology advice and verify against a children's formulary.