Safety-Related Labeling Changes

Available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy. Administration of Betaferon to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose

Trade Name

Betaferon

Updated Section

4.6. Fertility, pregnancy and lactation

Month

Jul, 2024