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Omvoh ® ▼ (mirikizumab)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
What is the dose regimen of Omvoh® (mirikizumab)?
The recommended mirikizumab dose regimen is described in the SmPC. It has 2 parts: induction and maintenance dose.
The induction and extended induction dose regimen were tested in the LUCENT-1 and LUCENT-2 clinical trials.1
The induction dose is 300 mg by intravenous infusion for at least 30 minutes at weeks 0, 4 and 8.2
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).2
- 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.
The maintenance and re-induction dose regimen were tested in LUCENT-2 clinical trial.1
The maintenance dose is 200 mg (i.e. two pre‑filled syringes or two pre‑filled pens) by subcutaneous injection every 4 weeks after completion of induction dosing.2
Patients should be evaluated after the 12‑week induction dosing and if there is adequate therapeutic response, transition to maintenance dosing.2
In case of a missed dose, instruct patients to inject as soon as possible. Thereafter, resume dosing every 4 weeks.2
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).2
- 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.
1D'Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. Published online June 29, 2023. https://doi.org/10.1056/NEJMoa2207940
2Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: 30 May 2023