Vedolizumab

SOURCE SCOPE — the eMC record fetched is the Entyvio 108 mg pre-filled pen SmPC, which covers ONLY the subcutaneous maintenance regimen and cross-refers the intravenous regimen to the separate 'Entyvio 300 mg powder for concentrate for solution for infusion' SmPC, which was NOT fetched. The UK intravenous induction and maintenance doses must be taken from that 300 mg SmPC. For reference only (US ENTYVIO prescribing information via openFDA — NOT UK labelling, verify against the UK 300 mg SmPC): 300 mg by intravenous infusion over approximately 30 minutes at Week 0 and Week 2; from Week 6 either continue 300 mg intravenously over approximately 30 minutes every eight weeks, or switch to 108 mg subcutaneously once every 2 weeks; discontinue in patients showing no evidence of therapeutic benefit by Week 14. OTHER SPC POINTS: treatment should be initiated and supervised by specialist healthcare professionals experienced in the diagnosis and treatment of ulcerative colitis or Crohn's disease. Missed subcutaneous dose — inject the next dose as soon as possible and then every 2 weeks thereafter (treatment interruption up to 46 weeks occurred in trials, with efficacy regained on re-initiation). Insufficient data to determine whether patients whose response decreases on subcutaneous maintenance would benefit from increased dosing frequency, and no data on transition from subcutaneous back to intravenous during maintenance. In responders, corticosteroids may be reduced and/or discontinued in accordance with standard of care. Elderly: no dose adjustment required. PAEDIATRIC: safety and efficacy in children aged 0 to 17 years have not been established and no data are available. Administration: after proper training in subcutaneous injection technique, a patient or caregiver may inject if the physician determines it appropriate.