Ruconest Pregnancy Warnings
Use is recommended only if clearly needed and the benefit outweighs the risk.
US FDA pregnancy category: B
One animal study revealed evidence of reproductive toxicity. There are no controlled data in human pregnancy.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
See references
Ruconest Breastfeeding Warnings
The amount of C1 esterase inhibitor excreted into breast milk is expected to be small due to its large molecular weight. Any C1 esterase inhibitor present in breast milk is likely destroyed in the infant's gastrointestinal tract and not absorbed (neonates may be an exception).
UK: Use is not recommended unless benefit outweighs risk.
US: Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments: Human plasma-derived C1 esterase inhibitor is considered first-line by an international consensus panel for prophylaxis and treatment of maternal hereditary angioedema during lactation.
See references
