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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).
Can Omvoh® (mirikizumab) be used in a patient with hepatic impairment?
No studies were conducted to evaluate the pharmacokinetics of mirikizumab in patients with hepatic impairment. No dose adjustments are needed in patients with hepatic impairment.
LUCENT Exclusion Criteria
Patients were excluded from the phase 3 LUCENT clinical trial program if they had an unstable or uncontrolled illness including hepatic disorders that would potentially affect patient safety within the study or confound efficacy assessment.1
Dose adjustments in patients with hepatic impairment
Mirikizumab has not been studied in these patient populations.2
- These conditions are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary.
Mirikizumab is a humanised IgG4 monoclonal antibody and is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgGs.2
Population pharmacokinetic analysis showed that total bilirubin (range of 1.5 to 29 µmol/L) did not affect mirikizumab pharmacokinetics.2
Special warnings and precautions for use related to hepatic enzyme elevations
Cases of drug-induced liver injury (including one case meeting Hy’s Law criteria) occurred in patients receiving mirikizumab in clinical trials.2
- Liver enzymes and bilirubin should be evaluated at baseline and monthly during induction (including extended induction period, if applicable).
Thereafter, liver enzymes and bilirubin should be monitored (every 1 ‑ 4 months) according to standard practice for patient management and as clinically indicated.
If increases in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) are observed and drug‑induced liver injury is suspected, mirikizumab must be discontinued until this diagnosis is excluded.2
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increases
ALT and AST increases were reported as an uncommon (≥ 1/1000 to < 1/100) adverse reaction in the clinical studies.2
In the first 12 weeks (LUCENT‑1),2
- ALT increased was reported in 0.4 % mirikizumab‑treated patients.
- AST increased was reported by 0.5 % mirikizumab‑treated patients.
All adverse reactions were reported as mild to moderate in severity and non‑serious.2
Over all mirikizumab treatment periods in the ulcerative colitis clinical development program (including the placebo‑controlled and open label induction and maintenance periods), there have been elevations of ALT to
- ≥ 3 x upper limit of normal (ULN) (2.0 %),
- ≥ 5 x ULN (0.7 %) and
- ≥ 10 x ULN (0.2 %)
and AST to
- ≥ 3 x ULN (2.1 %),
- ≥ 5 x ULN (1.1 %) and
- ≥ 10 x ULN (0.1 %)
in patients receiving mirikizumab.2
These elevations have been noted with and without concomitant elevations in total bilirubin.2
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
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