Drug products: ELOCTA
ATC code: B02BD02
Substances: efmoroctocog alfa
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 . 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) . The occurrence of hemophilia A in women is very rare and data in women is not available .
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).
Date of litterature search: 2020-05-20
Reviewed by: Carl-Olav Stiller, Diana Rydberg
Approved by: Karin Schenck-Gustafsson