NovoSeven is a medicine used to treat bleeding episodes and to prevent bleeding after surgical procedures. It is used in patients with the following conditions: - congenital haemophilia (a bleeding disorder present from birth) who have developed or are expected to develop ‘inhibitors’ (antibodies) against factor VIII or IX; - acquired haemophilia (a bleeding disease caused by the development of inhibitors to factor VIII); - congenital factor VII deficiency; - Glanzmann’s thrombasthenia (a rare bleeding disorder), who cannot be treated with a transfusion of platelets (components that help the blood to clot). The medicine is also used to treat patients with severe postpartum haemorrhage (serious bleeding after giving birth), when medicines that stimulate the muscles of the womb to contract (uterotonic medicines) are not effective at controlling the bleeding. NovoSeven contains the active substance eptacog alfa.
Therapeutic Indication
### Therapeutic indication NovoSeven is indicated 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 inhibitors to coagulation factors VIII or IX > 5 Bethesda units (BU); - in patients with congenital haemophilia who are expected to have a high anamnestic response to factor-VIII or factor-IX administration; - in patients with acquired haemophilia; - in patients with congenital factor-VII deficiency; - in patients with Glanzmann's thrombasthenia with antibodies to platelet glycoprotein (GP) IIb-IIIa and / or human leucocyte antigens (HLA), and with past or present refractoriness to platelet transfusions. - in patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.
Therapeutic Area (MeSH)
ATC Code
B02BD08
ATC Item
coagulation factor VIIa
Pharmacotherapeutic Group
Antihemorrhagics
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| eptacog alfa (activated) | N/A | Coagulation factor VIIa Recombinant Human |
EMA Name
NovoSeven
Medicine Name
NovoSeven
Aliases
N/ANo risk management plan link.
