Table 1: Approval status of products for the treatment of HAE-C1-INH (Europe and USA) < 18 years old.
|
Active ingredient/trade
name |
Approval in |
Approval for pediatric
patients |
Indication in
HAE-C1-INH |
Route of administration |
|
Human pdCq-INH concentrates |
|
|
|
|
|
Berinert® |
Europe USA |
Children, adolescent |
Acute attack, home
therapy |
Intravenous |
|
Cinryze® |
Europe USA |
Adolescent |
Acuteattack,
short-term and long-termprophylaxis, home therapy Long-termprophylaxis |
Intravenous |
|
Recombinat
human C1-INH concentrate |
|
|
|
|
|
Ruconest® |
Europe |
No |
Acute attack |
Intravenous |
|
Kallikrein
inhibitor and bradykynin receptor antagonist |
|
|
|
|
|
Icatibant/Firazyr® |
Europe, USA |
No |
Acute attack, home
therapy |
Subcutaneous |
|
Ecallantide/Kalbitor™ |
USA |
Adolescent > 16 yearsold |
Acute attack |
Subcutaneous |
|
Attenuated androgens |
|
Ԑ-Aminocaproicacid
(Amicar™) isnotapprovedfor
HAE therapy |
|
|
|
Danazol/Danatrol® |
Switzerland |
Adolescents |
Long-termprophylaxis |
Oral |
|
Danazol/Danokrin® |
Austria |
No |
Long-termpropylaxis |
Oral |
|
Danazol/Danocrine™ |
USA |
No specific approval
for children and adolescent |
Long-termpropylaxis |
Oral |
|
Stanozolol/Winstrol™ |
USA |
Children and adolescent |
Long-term propylaxis |
Oral |
|
Antifibrinolytics |
|
|
|
|
|
Tranexamicacid/Cyklokapron® |
Austria |
No specific approval
for children and adolescent |
HAE |
Oral |
|
|
Switzerland |
Children and adolescent |
Long-term prophylaxis,
acute attacks (for prodromal
symptoms) |
Oral |
|
|
Germany |
Children and adolescent |
Long-term prophylaxis,
short-term propylaxis posible |
Oral |