Pregnancy & Breast-feeding
The New summary of product characteristics state:
“If clinically needed, the use of AVONEX may be considered during pregnancy and breast-feeding.” 1
Until now, a lack of consensus in the literature regarding MS treatment with interferon beta up to and during pregnancy has put doubts in the minds of HCPs.
To address this lack of evidence, a European interferon beta pregnancy registry was established and a population-based cohort study conducted using healthcare register data from Finland and Sweden.2
The principal findings were:2
A large amount of data (more than 1000 pregnancy outcomes) from pregnancy registries and post-marketing experience indicate no adverse effect on pregnancy or infant outcomes, after exposure to interferon beta before conception and/or during pregnancy.2
A prospective European interferon beta pregnancy registry contained 948 known pregnancy outcomes. The reported overall rate of congenital anomalies in live births and of spontaneous abortions was in line with the rates observed both in the general population and in MS patients not receiving any treatment.2
In a retrospective register-based study, data from 3054 pregnancy outcomes from women with MS were analysed. No evidence was found of an increased risk of serious adverse pregnancy outcomes, including spontaneous abortions and major congenital anomalies, after exposure to interferon beta before and/or during pregnancy compared to the women with MS that were unexposed to any MS disease modifying drug within the study. Further it was found that interferon beta exposure does not affect the mean birth weight and risk of preterm birth.2
A large amount of data (more than 1000 pregnancy outcomes) from registries and post-marketing experience indicates no increased risk of major congenital anomalies after pre-conception exposure to interferon beta or such exposure during the first trimester of pregnancy. However, the duration of exposure during the first trimester is uncertain, because data was 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, 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 does not suggest an increased risk so far.
If clinically needed, the use of AVONEX may be considered during pregnancy.
Limited information available on the transfer of interferon beta-1a into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1a excreted in human milk are negligible.
No harmful effects on the breastfed newborn/infant are anticipated.
Avonex can be used during breast-feeding.