Conestat alfa

ArticlesLactation Safety InformationNew Medicines ·
18484611000001104

Articles

Lactation Safety Information

C1-esterase inhibitor
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

New Medicines

RuconestHereditary angioedema - treatment in children aged 2 to 17 years

Information

Ruconest
Pharming Group NV
Santarus

Development and Regulatory status

Launched
Launched
None
May 2020
Yes
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 [2].

Category

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 [1].
Hereditary angioedema - treatment in children aged 2 to 17 years
Intravenous

Evidence based evaluations