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Omvoh ® ▼ (mirikizumab)
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Contraception, pregnancy and lactation during therapy with Omvoh® (mirikizumab)
Women should use effective contraception for at least 10 weeks after the last Omvoh dose. The use of mirikizumab during pregnancy should be avoided. Use during breastfeeding requires an individual decision.
Content overview
Information on Contraception, Family Planning, Pregnancy and Breastfeeding
LUCENT and VIVID Clinical Study Protocols
Information on Contraception, Family Planning, Pregnancy and Breastfeeding
For complete information on contraception, family planning, pregnancy and breastfeeding, please refer to the Omvoh Summary of Product Characteristics, in particular the section1
- 4.6 Fertility, pregnancy and lactation
In the clinical trials, several women became pregnant while using mirikizumab. Below you will find more information about these pregnancies in the clinical trials on Crohn's disease and ulcerative colitis.
LUCENT and VIVID Clinical Study Protocols
Per the protocol for the LUCENT and VIVID clinical trials, women of childbearing potential were required to
Pregnancies During the Mirikizumab Clinical Studies
Pregnancies in Mirikizumab-Exposed Female Study Participants
As of October 4, 2023, 22 women exposed to mirikizumab became pregnant during an ulcerative colitis, or Crohn's disease clinical study.3 For details, please see Pregnancies in Female Participants Exposed to Mirikizumab.
Outcome |
Number of Events (n) |
Crohn's disease (N=11) |
|
Normal outcomea |
4 |
Elective abortion |
1 |
Spontaneous abortion |
4 |
Unknown, lost to follow-up |
1 |
Pregnancy still ongoing |
1 |
Ulcerative colitis (N=11) |
|
Normal outcomeb |
2 |
Elective abortion |
2 |
Spontaneous abortion |
1 |
Unknown, lost to follow-up |
2 |
Pregnancy still ongoing |
3 |
Birth defectc |
1 |
Abbreviations: n = number of events; N = number of participants in the specified category.
aOne of the 4 cases was a low-weight birth with a healthy baby.
bOne of the 2 cases was a preterm birth with a healthy baby.
cThe birth defect was Treacher Collins syndrome.
Pregnancies in Partners of Male Study Participants Exposed to Mirikizumab
As of October 4, 2023, 30 partners of male participants became pregnant during the male participants' participation in a mirikizumab clinical study for ulcerative colitis, or Crohn's disease.3 For details, please see Pregnancies in Partners of Male Participants Exposed to Mirikizumab.
Outcome |
Number of Events (n) |
Crohn's disease (N=12) |
|
Normal outcome |
9 |
Elective abortion |
0 |
Spontaneous abortion |
0 |
Unknown, lost to follow-up |
2 |
Pregnancy still ongoing |
1 |
Ulcerative colitis (N=18) |
|
Normal outcome |
7 |
Elective abortion |
0 |
Spontaneous abortion |
6 |
Unknown, lost to follow-up |
4 |
Pregnancy still ongoing |
1 |
Abbreviations: n = number of events; N = number of participants in the specified category.
Background Risk
All pregnancies have a background risk of birth defects, loss, or other adverse outcomes.3
In the US general population, in clinically recognized pregnancies the estimated background risk of
- major birth defects is 2% to 4%, and
- miscarriage is 15% to 20%.3
Among patients with inflammatory bowel disease, results from observational studies indicate that the incidence of
- congenital malformations ranges from 2.7% to 9.0%, and
- spontaneous abortions ranges from 3% to 17%.3
Among patients with Crohn's disease, results from observational studies indicate that the incidence of
- congenital malformations ranges from 1.9% to 8.6%, and
- spontaneous abortions ranges from 4.4% to 15.9%.3
Pregnancy Exposure Registry
There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mirikizumab during pregnancy in the United States.3
Information regarding a mirikizumab pregnancy exposure registry outside the United States is not currently available.3
References
1Omvoh 300 mg concentrate for solution for infusion [summary of product characteristics] Eli Lilly Nederland B.V., The Netherlands (UK)
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.
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: 26 January 2025