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Effects on fertility: The effects of ADYNOVATE on fertility have not been established.
Use in pregnancy (Category B2): The safety of ADYNOVATE for use in pregnant women has not been established. Animal reproduction studies with recombinant factor VIII, including ADYNOVATE, have not been conducted. Healthcare professionals should balance the potential risks and only prescribe ADYNOVATE if clearly needed.
Use in lactation: The safety of ADYNOVATE for use in lactating women has not been established. It is not known if ADYNOVATE or its metabolites are excreted in human milk. Healthcare professionals should balance the potential risks and only prescribe ADYNOVATE to a breastfeeding woman if clearly needed.
