Immunosuppressives and biologics during pregnancy and lactation
ÖGGH · 2019 · Austria
Source and licence
- Authors
- Antonia Puchner, Hans Peter Gröchenig, Judith Sautner et al.
- Title
- Immunosuppressives and biologics during pregnancy and lactation
- Journal
- Wiener Klinische Wochenschrift, 2019
- Licence
- CC BY 4.0
- Changes
- Verbatim excerpts; formatting adapted
Full text retrieved 2026-10-27 from Europe PMC · PMC6342891
Licence statement of the original publication
Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
This page reproduces excerpts of the original publication; the original is authoritative. It has not been reviewed by a physician, does not state a recommendation of Medelix and does not replace medical advice. The guideline may have been updated since.
Open the original publication →Full text on Europe PMC
Recommendations
Verbatim, with grade of recommendation or strength of consensus where given.
Pregnancy
- Due to deficient data, apremilast is not to be administered during pregnancy.EL 5, RG D
Lactation
- Due to insufficient data, breastfeeding under apremilast is currently not recommended.EL 5, RG D
Pregnancy
- After onset of pregnancy, remission-maintaining treatment with thiopurines, azathioprine, 6‑mercaptopurine, may be continued over the entire course of pregnancy.EL 2, RG B
Lactation
- Breastfeeding is compatible with azathioprine and/or 6‑mercaptopurine therapy.EL 3, RG B
Pregnancy
- Cyclophosphamide is teratogenic and is to be discontinued 3 months prior to planned pregnancy. In the presence of mothers’ severe or life-threatening medical conditions, and subsequent to failure of other treatments, its administration may be considered in the second and third trimesters.EL 2, RG C
Lactation
- Cyclophosphamide must not be administered in the lactation period.EL 4, RG D
Pregnancy
- Following strict indications, cyclosporine A and tacrolimus may be administered in pregnancy.EL 2, RG B
Lactation
- Breastfeeding seems to be compatible with cyclosporine A and tacrolimus treatment.EL 3, RG C
Pregnancy
- Due to insufficient data, leflunomide should be discontinued 2 years prior to planned pregnancy. In any case, in women wishing to conceive or in unintended pregnancies, wash-out procedures with cholestyramine are recommended.EL 2, RG C
Lactation
- Due to insufficient data, breastfeeding cannot be currently recommended under leflunomide.EL 4, RG C
Pregnancy
- Methotrexate is teratogenic and must not be taken in pregnancy. Methotrexate therapy is to be discontinued 3 months prior to planned pregnancy.EL 2, RG B
Lactation
- Methotrexate must not be taken while breastfeeding.EL 2, RG B
Pregnancy
- Mycophenolic acid is a teratogenic agent and must not be taken during pregnancy. Treatment with mycophenolic acid should be discontinued 6 weeks prior to planned pregnancy.EL 2, RG B
Lactation
- Due to insufficient data, breastfeeding under mycophenolic acid is currently not recommended.EL 2, RG B
Pregnancy
- Due to insufficient data, tofacitinib should be discontinued at least 6 weeks prior to planned pregnancy.EL 4, RG C
Lactation
- Due to insufficient data, breastfeeding under tofacitinib cannot currently be recommended.EL 5, RG D
Pregnancy
- Whenever clinically indicated, anti-TNF-α antibody therapy is feasible throughout pregnancy (infliximab: EL 2, RG B; adalimumab: EL 2, RG B; golimumab: EL 4, RG C). In stable clinical remission, anti-TNF-α therapy may be discontinued at the end of the second trimester (approximately 24th GW) in order to avoid infants’ exposure, even though there is no evidence of increased risks of postpartum malformation or infection.EL 2, RG B
Lactation
- As only minimal concentrations of anti-TNF-α antibodies are detected in breast milk, breastfeeding is compatible with anti-TNF-α treatment.EL 3, RG B
Pregnancy
- Certolizumab may be applied throughout pregnancy.EL 2, RG B
Lactation
- Breastfeeding is compatible with certolizumab treatment.EL 2, RG B
Pregnancy
- Etanercept may be applied until the 32nd GW and, if required, throughout pregnancy.EL 2, RG B
Lactation
- Breastfeeding appears to be compatible with etanercept.EL 4, RG D
Pregnancy
- Due to insufficient data, application of abatacept during pregnancy should be avoided.EL 4, RG D
Lactation
- Due to insufficient data, breastfeeding under abatacept cannot currently be recommended.EL 4, RG D
Pregnancy
- In the absence of alternative treatments, anakinra may be applied during pregnancy.EL 4, RG D
Lactation
- Due to insufficient data, breastfeeding under anakinra cannot currently be recommended.EL 5, RG D
Pregnancy
- Due to insufficient data, application of belimumab during pregnancy should be avoided.EL 4, RG D
Lactation
- Due to insufficient data, breastfeeding under belimumab cannot currently be recommended.EL 4, RG D
Pregnancy
- Due to insufficient data, application of rituximab during pregnancy should be avoided. In the presence of severe disease progression and lacking treatment alternatives, its application is acceptable prior to conception or in the first trimester.EL 4, RG D
Lactation
- Due to insufficient data, breastfeeding under rituximab cannot currently be recommended.EL 4, RG D
Pregnancy
- Due to insufficient data, application of secukinumab during pregnancy should be avoided.EL 5, RG D
Lactation
- Due to insufficient data, breastfeeding under secukinumab cannot currently be recommended.EL 5, RG D
Pregnancy
- Due to insufficient data, application of tocilizumab during pregnancy should be avoided.EL 4, RG D
Lactation
- Due to insufficient data, breastfeeding under tocilizumab cannot currently be recommended.EL 4, RG D
Pregnancy
- Due to insufficient data, application of ustekinumab during pregnancy should be avoided.EL 4, RG D
Lactation
- Due to insufficient data, breastfeeding under ustekinumab cannot currently be recommended.EL 5, RG D
Pregnancy
- Due to insufficient data, application of vedolizumab during pregnancy should be avoided; however, in the presence of severe disease progression and lacking treatment alternatives, its application is acceptable in pregnancy.EL 4, RG C
Lactation
- Due to insufficient data, breastfeeding under vedolizumab cannot currently be recommended but it appears to be unproblematic.EL 5, RG D
Abstract
An increasing and early-onset use of immunosuppressives and biologics has become more frequently seen among patients with inflammatory bowel diseases (IBD) and rheumatic disorders. Many women in their childbearing years currently receive such medications, and some of them in an interdisciplinary setting. Many questions arise in women already pregnant or wishing to conceive with respect to continuing or discontinuing treatment, the risks borne by the newborns and their mothers and long-term safety. Together with the Austrian Society of Rheumatology and Rehabilitation, the IBD working group of the Austrian Society of Gastroenterology and Hepatology has elaborated consensus statements on the use of immunosuppressives and biologics in pregnancy and lactation. This is the first Austrian interdisciplinary consensus on this topic. It is intended to serve as a basis and support for providing advice to our patients and their treating physicians.
Contents of the original publication
The section headings of the original.
- Introduction
- Immunosuppressives and disease-modifying antirheumatic drugs
- Apremilast
- Azathioprine/6-mercaptopurine
- Cyclophosphamide
- Cyclosporine A, tacrolimus
- Leflunomide
- Methotrexate
- Mycophenolate mofetil
- Tofacitinib
- Biologics: TNF-α inhibitors
- Infliximab, adalimumab, golimumab
- Certolizumab
- Etanercept
- Other biologics
- Abatacept
- Anakinra
- Belimumab
- Rituximab
- Secukinumab
- Tocilizumab
- Ustekinumab
- Vedolizumab
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