Mirikizumab

Crohn's disease — Induction: 900 mg by intravenous infusion over at least 90 minutes at Week 0, Week 4 and Week 8. Maintenance: 300 mg subcutaneously at Week 12 and every 4 weeks thereafter (given as two consecutive injections of 100 mg and 200 mg in any order). Prior to treatment initiation: evaluate patients for tuberculosis infection, obtain liver enzymes and bilirubin levels, and complete all age-appropriate vaccinations according to current immunization guidelines. Intravenous doses are diluted in 0.9% sodium chloride or 5% dextrose (ulcerative colitis 300 mg = one 300 mg/15 mL vial in 50, 100 or 250 mL; Crohn's disease 900 mg = three vials in 100 or 250 mL, discarding 45 mL from the bag first); do not mix with other drugs or infuse through the same line as other solutions; flush the line at the end of the infusion at the same rate. Paediatric: safety and effectiveness have not been established. Geriatric: no clinically meaningful pharmacokinetic differences in subjects 65 years and older, but study numbers were insufficient to determine a different response. SOURCE CAVEAT: no UK SPC section was captured in the bundle; the regimen above is from the US prescribing information for Omvoh and must be verified against the UK SPC before publication.