ATC kod: B02BD02
Eftersom substansen nästan bara används av män har analys avseende könsskillnader inte bedömts 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).
Nästan enbart män hämtade ut läkemedel innehållande koagulationsfaktor VIII (ATC-kod B02BD02) på recept i Sverige år 2019, totalt 430 män och 4 kvinnor [4].
Uppdaterat: 2021-06-07
Litteratursökningsdatum: 2020-05-20
Faktagranskat av: Carl-Olav Stiller, Diana Rydberg
Godkänt av: Karin Schenck-Gustafsson