Rebif Use In Pregnancy & Lactation

Pregnancy: 22 mcg: Data from registries and post-marketing experience (more than 1,000 pregnancy outcomes) indicates no increased risk of major congenital anomalies after pre-conception exposure to interferon beta or such exposure during the first trimester of pregnancy.
Based on Nordic registers, the relative risk of live births with congenital anomalies (95% confidence interval) of IFN-beta-exposed only pregnancies was 0.52 (0.27-0.99) when compared to those unexposed to any disease modifying drugs. In post-marketing experience, the prevalence of live births with congenital anomalies in IFN-beta exposed pregnancies was 1.8% in line with that in the general population (2.1-4.1%).
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 the pregnancy was detected and/or confirmed. Experience with exposure during the second and third trimester is very limited.
If clinically needed, the use of IFN β-1a may be considered during pregnancy. A decision to use IFN β-1a should be made based on the benefit of therapy for the pregnant woman and any potential risk to the foetus.
44 mcg: There is limited information on the use of Rebif in pregnancy. Available data indicates that there may bean increased risk of spontaneous abortion. Therefore initiation of treatment is contraindicated during pregnancy (see Contraindications).
Women of childbearing potential: 44 mcg: Women of child-bearing potential should take appropriate contraceptive measures. If the patient becomes pregnant or plans to become pregnant while taking Rebif she should be informed of the potential hazards and discontinuation of therapy should be considered (see Pharmacology: Toxicology: Preclinical safety data under Actions). In patients with a high relapse rate before treatment has started, the risk of a severe relapse following discontinuation of Rebif in the event of pregnancy should be weighed against a possible increased risk of spontaneous abortion.
Breastfeeding: 22 mcg: Based on the current information available on the transfer of interferon beta-1a into breast milk, together with the chemical/physiological characteristics of interferon beta, it suggests that levels of interferon beta-1a excreted in human milk are negligible. The potential for harmful effect on the breastfed newborn/infant is low. Rebif can be used during breast-feeding.
44 mcg: It is not known whether Rebif is excreted in human milk. Because of the potential for serious adverse reactions in breast-fed infants, a decision should be made whether to discontinue breast-feeding or Rebif therapy.