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Omvoh ® ▼ (mirikizumab)
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Omvoh® (mirikizumab): Use in pregnancy, breast-feeding and impact on fertility
Please find below available information regarding the use of mirikizumab in pregnancy, breast-feeding and the impact on fertility.
- Pregnancies in Mirikizumab-Exposed Study Participants
- Pregnancies in Partners of Male Study Participants Exposed to Mirikizumab
Information from the label
Women of childbearing potential
Women of childbearing potential should use an effective method of contraception during treatment and for at least 10 weeks after treatment.1
There is a limited amount of data from the use of mirikizumab in pregnant women.1
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.1
As a precautionary measure, it is preferable to avoid the use of mirikizumab during pregnancy.1
It is unknown whether mirikizumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period.1
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from mirikizumab therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.1
The effect of mirikizumab on human fertility has not been evaluated.1
No reproductive organ weight or histopathology effects were observed in sexually mature cynomolgus monkeys that received mirikizumab once weekly for 26 weeks, at a dose of 100 mg/kg (at least 30 times the human maintenance dose).1
LUCENT Clinical Study Protocols
Per the protocol for the LUCENT-1 and LUCENT-2 studies, women of childbearing potential were required to
- test negative for pregnancy within 24 hours prior to mirikizumab exposure, and
- either agree to remain abstinent or use 2 effective methods of contraception for the entirety of the study.2
Any pregnancy that occurred during study participation required permanent discontinuation.2
Pregnancies During the Phase 3 Mirikizumab Ulcerative Colitis Clinical Studies
Pregnancies in Mirikizumab-Exposed Study Participants
As of December 6, 2021, 5 women had become pregnant during a phase 3 mirikizumab ulcerative colitis study. Of those 5 participants, 4 had a maternal exposure to mirikizumab during pregnancy and 1 had a maternal exposure to mirikizumab before pregnancy. Of the 5 pregnancies,
Pregnancies in Partners of Male Study Participants Exposed to Mirikizumab
As of December 6, 2021, 3 partners of male participants became pregnant during the male participants' study participation. Of the 3 partner pregnancies,
1Omvoh [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
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
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
4Committee for Medicinal Products for Human Use (CHMP); European Medicines Agency. Assessment report: Omvoh. EMA/CHMP/197960/2023. March 30, 2023. Accessed September 20, 2023. https://www.ema.europa.eu/documents/assessment-report/omvoh-epar-public-assessment-report_en.pdf
▼ 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: 20 September 2023