ATC code: B02BD02
As the substance is almost exclusively used by men, analyses on sex or gender differences have not been considered relevant.
Efmoroctocog alfa is a first-in-class recombinant factor VIII-Fc fusion protein (rFVIIIFc) used in treatment of acute bleeding episodes, perioperative management and routine prophylaxis in previously treated males with severe hemophilia A [1]. Hemophilia A (deficiency in coagulation factor VIII) is an inherited X-linked disease and thus affects primarily men although women also can be affected (for example because of skewed inactivation of chromosome X) [2]. The occurrence of hemophilia A in women is very rare and data in women is not available [3].
No studies with a clinically relevant sex analysis regarding pharmacokinetics and dosing of efmoroctocog alfa have been found.
No studies with a clinically relevant sex analysis regarding effects of efmoroctocog alfa have been found.
No studies with a clinically relevant sex analysis regarding adverse effects of efmoroctocog alfa have been found.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Updated: 2021-06-07
Date of litterature search: 2020-05-20
Reviewed by: Carl-Olav Stiller, Diana Rydberg
Approved by: Karin Schenck-Gustafsson