Active Ingredient: Mirikizumab
Mirikizumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravenous, 300 milligrams mirikizumab, once every 4 weeks, 3 doses in total, over the duration of 12 weeks. Afterwards, subcutaneous, 200 milligrams mirikizumab, once every 4 weeks.
Regimen B: Intravenous, 300 milligrams mirikizumab, once every 4 weeks, 6 doses in total, over the duration of 24 weeks. Afterwards, subcutaneous, 200 milligrams mirikizumab, once every 4 weeks.
The recommended mirikizumab dose regimen has 2 parts.
The induction dose is 300 mg by intravenous infusion for at least 30 minutes at weeks 0, 4 and 8.
The maintenance dose is 200 mg by subcutaneous injection every 4 weeks after completion of induction dosing.
Patients should be evaluated after the 12-week induction dosing and if there is adequate therapeutic response, transition to maintenance dosing. For patients who do not achieve adequate therapeutic benefit at week 12 of induction dosing, mirikizumab 300 mg by intravenous infusion may be continued at weeks 12, 16 and 20 (extended induction therapy). If therapeutic benefit is achieved with the additional intravenous therapy, patients may initiate mirikizumab subcutaneous maintenance dosing (200 mg) every 4 weeks, starting at week 24. Mirikizumab should be discontinued in patients who do not show evidence of therapeutic benefit to extended induction therapy by week 24.
Patients with loss of therapeutic response during maintenance treatment may receive 300 mg mirikizumab by intravenous infusion every 4 weeks, for a total of 3 doses (re-induction). If clinical benefit is achieved from this additional intravenous therapy, patients may resume mirikizumab subcutaneous dosing every 4 weeks. The efficacy and safety of repeated re-induction therapy have not been evaluated.
In case of a missed dose, instruct patients to inject as soon as possible. Thereafter, resume dosing every 4 weeks.
Induction dose by intravenous infusion for at least 30 minutes.
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