Adalimumab

VERBATIM UK SPC §4.2 (RA): 'The recommended dose of AMGEVITA for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with AMGEVITA.' VERBATIM §4.2 (AS/axSpA/PsA): 'The recommended dose of AMGEVITA for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.' DOSE ESCALATION (RA monotherapy), VERBATIM: 'In monotherapy, some patients who experience a decrease in their response to AMGEVITA 40 mg every other week may benefit from an increase in dose to 40 mg adalimumab every week or 80 mg every other week.' RESPONSE REVIEW: 'Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period.' DOSE INTERRUPTION: 'There may be a need for dose interruption, for instance before surgery or if a serious infection occurs. Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.' PLAQUE PSORIASIS (adults, UK SPC): 'an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose' — continued therapy beyond 16 weeks should be carefully reconsidered in a non-responder. maxDose left empty deliberately: neither label states a dose ceiling with an explicit maximum cue; the every-week / 80 mg every-other-week option above is an escalation, not a stated maximum. SCOPE — OTHER INDICATIONS NOT COVERED BY THE UK FETCH: the eMC §4.2 text was truncated at the source-fetch limit part-way through the psoriasis paragraph, so the UK hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis regimens were NOT retrieved. From the US label in this bundle only (cross-check, may differ from UK): Crohn's disease adults 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15, then 40 mg every other week starting on Day 29; ulcerative colitis adults the same, discontinuing in patients without evidence of clinical remission by eight weeks (Day 57); hidradenitis suppurativa adults Day 1 160 mg, Day 15 80 mg, Day 29 and subsequent doses 40 mg every week or 80 mg every other week. ADMINISTRATION: treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of the indicated conditions; patients may self-inject after proper training in injection technique; patients should be given the Patient Reminder Card. PRESENTATION: the UK source product is AMGEVITA HCF (high-concentration formulation); the US source product is supplied as 40 mg/0.8 mL pen, prefilled syringe and institutional vial — presentations and strengths differ between products, so check the specific product before converting a dose to a volume.

dosePerKg is null because the paediatric regimen is WEIGHT-BANDED with fixed milligram doses, not a per-kilogram calculation. The UK SPC §4.2 fetch was truncated before the paediatric sections, so the bands below come from the US label in this bundle (IDACIO) — US labelling may differ from UK. JUVENILE IDIOPATHIC ARTHRITIS, VERBATIM §2.2 (2 years of age and older): '10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other week; 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week; 30 kg (66 lbs) and greater 40 mg every other week.' PAEDIATRIC CROHN'S DISEASE, VERBATIM §2.3 (6 years of age and older): '17 kg (37 lbs) to less than 40 kg (88 lbs) — Day 1: 80 mg, Day 15: 40 mg, then 20 mg every other week starting on Day 29; 40 kg (88 lbs) and greater — Day 1: 160 mg (single dose or split over two consecutive days), Day 15: 80 mg, then 40 mg every other week starting on Day 29.' Route is subcutaneous injection. maxDose left empty deliberately: no explicit maximum-dose cue is given for the paediatric bands. concentration set to null deliberately: the two source products differ in presentation (the US product is 40 mg/0.8 mL; the UK source product is a high-concentration formulation whose strength per mL was not in the fetched section), so a single mg/mL figure cannot be taken from this bundle. UK paediatric psoriasis and uveitis regimens were NOT retrieved. Verify any under-18 dose against a children's formulary before administration. §4.8 (UK): 'In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult patients.'