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Omvoh ® ▼ (mirikizumab)
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Can Omvoh® (mirikizumab) be used in a patient with renal impairment?
Specific clinical pharmacology studies to evaluate the effects of renal impairment on the pharmacokinetics of mirikizumab have not been conducted. No dosing adjustments are considered necessary in patients with renal impairment.
LUCENT exclusion criteria
Patients were excluded from the phase 3 LUCENT clinical trial program if they had an unstable or uncontrolled illness including renal disorders that would potentially affect patient safety within the study or confound efficacy assessment.1
Patients with renal impairment are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary. 2
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
In the population PK analysis,2
- mean apparent clearance was 0.0229 L/hr and
- the mean elimination half‑life is approximately 9.3 days in patients with ulcerative colitis.
- Clearance is independent of dose.2
Population pharmacokinetic analysis showed that creatinine clearance (range of 36.2 to 291 mL/min) did not affect mirikizumab pharmacokinetics.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