Interferon beta-1a Pregnancy and Breastfeeding Warnings
Interferon beta-1a Pregnancy Warnings
Animal studies have failed to reveal evidence of teratogenicity, but abortifacient activity has been demonstrated at higher than recommended doses of interferon beta. Non-dose-related increases in spontaneous abortions and fetal and neonatal deaths were observed in pregnant cynomolgus monkeys treated with daily intramuscular doses of Rebif(R). There are no controlled data in human pregnancy. Seven women became pregnant during Rebif(R) clinical studies; 5 women delivered normal babies at full term and 2 women had spontaneous abortions. Among 32 pregnant patients treated with Rebif(R) who were followed in a pregnancy registry, 29 women had live births with no abnormalities at birth, 2 had spontaneous abortions, and 1 had a stillbirth. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
FDA pregnancy category: C Interferon beta-1a should be used during pregnancy only if the potential benefit outweighs the potential risk.
Interferon beta-1a Breastfeeding Warnings
There are no data on the excretion of interferon beta-1a into human milk. The manufacturer of Rebif(R) recommends that caution be used when administering interferon beta-1a to nursing women.
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