BETAFERON and pregnancy – Excerpt from the European Summary of Product Characteristics
The pregnancy and breastfeeding sections of the European Summary of Product Characteristics for BETAFERON were reformulated in September 2019 to reflect current evidence .
A large amount of data (more than 1000 pregnancy outcomes) from interferon beta registries, national registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure or exposure during the first trimester of pregnancy. However, the duration of exposure during the first trimester is uncertain, because data were collected when interferon beta use was contraindicated during pregnancy, and treatment likely interrupted when pregnancy was detected and/or confirmed. Experience with exposure during the second and third trimester is very limited.
Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion. The risk of spontaneous abortions in pregnant women exposed to interferon beta cannot adequately be evaluated based on the currently available data, but the data do not suggest an increased risk so far.
If clinically needed, the use of BETAFERON may be considered during pregnancy.
Limited information available on the transfer of interferon beta into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1b excreted in human milk are negligible. No harmful effects on the breastfed newborn/infant are anticipated.
BETAFERON can be used during breast-feeding.
No investigations on fertility have been conducted (see section 5.3).
- BETAFERON® European Summary of Product Characteristics, October 2020. Available at: https://www.ema.europa.eu/en/documents/product-information/betaferon-epar-product-information_en.pdf Return to content