Cevenfacta is a medicine used to treat bleeding episodes and to prevent bleeding in patients undergoing surgery. It is used in adults and adolescents aged 12 years or older with inherited haemophilia who have developed or are expected to develop inhibitors (antibodies) against coagulation factors VIII or IX (proteins involved in blood clotting), or who are unlikely to respond to treatment with these coagulation factors. Cevenfacta contains the active substance eptacog beta (activated).
Therapeutic Indication
CEVENFACTA is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: * in patients with congenital haemophilia with high\-responding inhibitors to coagulation factors VIII or IX (i.e. ?5 Bethesda Units (BU)); * in patients with congenital haemophilia with low titre inhibitors (BU \<5\), but expected to have a high anamnestic response to factor VIII or factor IX administration or expected to be refractory to increased dosing of FVIII or FIX.
Therapeutic Area (MeSH)
ATC Code
B02BD08
ATC Item
N/A
Pharmacotherapeutic Group
Antihemorrhagics
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Eptacog beta (activated) | N/A | Eptacog beta (activated) |
EMA Name
Cevenfacta
Medicine Name
Cevenfacta
Aliases
N/ANo risk management plan link.