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Omvoh ® ▼ (mirikizumab)
This information is intended for UK registered healthcare professionals only in response to your search for information. For current information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk
Omvoh® (mirikizumab): Use in patients undergoing medical procedure or surgery
The decision to stop mirikizumab therapy for medical procedures or surgery should be based on the health care provider's clinical judgment. In phase 3 studies, patients paused mirikizumab for major surgery.
Content Overview
Management of Omvoh Patients During Surgeries
Although the Omvoh Summary of Product Characteristics does not contain any specific instructions for the procedure for surgery, mirikizumab can increase the risk of serious infections, which should be taken into account in patients with planned surgery. For complete information, please refer to the Omvoh Summary of Product Characteristics, in particular the sections
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.8 Undesirable effects
Below you will find more information on the procedure for surgery in the clinical trials of Crohn's disease and ulcerative colitis.
Crohn's Disease: Study Drug Management and Exclusion Criteria for Surgery in VIVID-1
Exclusion Criteria for Surgery
Summary of VIVID-1 Exclusion Criteria Related to Surgeries summarizes the VIVID-1 exclusion criteria related to surgeries.
Exclusion Criteria |
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Gastrointestinal criteria |
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Additional exclusion criteria |
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Temporarily Holding Mirikizumab for Major Surgery
During VIVID-1, patients who required major surgery would temporarily stop taking study drug.1
After surgery and adequate wound healing, patients were allowed to start taking study drug again.1
Study Drug Discontinuation for Surgery
Patients discontinued study drug if they required surgery for Crohn's disease with the exception of drainage of an abscess or seton placement.1
Ulcerative colitis: Study drug management and exclusion criteria for surgery in LUCENT-1 and LUCENT-2
LUCENT-1 is a 12-week, phase 3, multicenter, randomized, double-blind, parallel-arm, placebo-controlled study of mirikizumab, a p19-directed anti-interleukin-23 (anti-IL-23) antibody. The study was conducted to evaluate efficacy and safety in adult patients with moderately to severely active ulcerative colitis (UC), with a modified Mayo score of 4 to 9 points and centrally read Mayo endoscopic subscore ≥2, who had an inadequate response, loss of response, or an intolerance to corticosteroids, immunosuppressants, biologic therapies, or tofacitinib.2
LUCENT-2 is a 40-week, phase 3, multicenter, randomized, double-blind, parallel-arm, placebo-controlled, maintenance study that evaluated the safety and efficacy of mirikizumab, a p19-directed anti-IL-23 antibody, conducted in adult patients with moderately to severely active UC who completed the LUCENT-1 study.2
Temporarily holding mirikizumab for major surgery
During LUCENT-1 and -2, patients who required major surgery would temporarily stop taking study drug.1
After surgery and adequate wound healing, patients were allowed to start taking study drug again.1
Exclusion Criteria for Surgery
Summary of LUCENT-1 and LUCENT-2 Exclusion Criteria Related to Surgeries summarizes the LUCENT-1 and LUCENT-2 exclusion criteria related to surgeries.
Exclusion Criteria |
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Gastrointestinal criteria |
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Additional exclusion criteria for LUCENT-2 |
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Abbreviation: UC = ulcerative colitis.
aSome patients with limited colonic surgery, eg, segmental colonic resection, may have been allowed in the study if it would not affect assessment of efficacy.
Study drug discontinuation for surgery
Patients discontinued study drug if they required a colectomy, proctocolectomy, or partial colectomy during LUCENT-1 or LUCENT-2.1
References
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2D'Haens G, Dubinsky M, Kobayashi T, et al; LUCENT Study Group. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2023;388(26):2444-2455. https://doi.org/10.1056/NEJMoa2207940
Links to references and third-party websites are provided solely for your convenience and to facilitate easy access to the sources cited.
▼ 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