15 June 2020This table provides a summary of clinical factors to consider when using alternative complement regulatory proteins to Berinert (C1-esterase inhibitor). Supplies of Berinert are expected…
22 May 2017Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Antihistamines Non-sedating antihistamines (NSA) preferred over…
Lactation Safety Information
Conestat alfa is the recombinant analogue of human C1-esterase inhibitor
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infants GI tract
22 May 2017
RuconestHereditary angioedema - treatment in children aged 2 to 17 years
Pharming Group NV
Development and Regulatory status
May 20Approved in EU [3,4].
Mar 20CHMP issues positive opinion for an extension to the existing indication to include children from the age of 2 years and above. The full indication for Ruconest will be: for treatment of acute angioedema attacks in adults, adolescents, and children (aged 2 years and above) with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency .
Recombinant human C1 esterase inhibitor
The incidence is approximately 1 in 50,000 although there may be variation geographically. HAE can affect people of any ethnic group or gender. Usually it presents in childhood, with the mean age of onset being between 8 and 12 years .
Hereditary angioedema - treatment in children aged 2 to 17 years