Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Efmoroktokog alfa

Klassificering: B

Preparat: ELOCTA

ATC kod: B02BD02

Substanser: efmoroktokog alfa

Sammanfattning

Eftersom substansen nästan bara används av män har analys avseende könsskillnader inte bedömts relevant.

Additional information

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 carrying the mutation may have some excess bleeding. The occurrence of hemophilia A in women is very rare and data in women is not available [2].

Pharmacokinetics and dosing

No studies with a clinically relevant sex analysis regarding pharmacokinetics and dosing of efmoroctocog alfa have been found.

Effects

No studies with a clinically relevant sex analysis regarding effects of efmoroctocog alfa have been found.

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of efmoroctocog alfa have been found.

Reproductive health issues

No studies with a clinically relevant analysis regarding fertility or reproduction of efmoroctocog alfa have been found. Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Försäljning på recept

Nästan enbart män hämtade ut läkemedel innehållande koagulationsfaktor VIII (ATC-kod B02BD02) på recept i Sverige år 2019, totalt 430 män och 4 kvinnor [3].

Uppdaterat: 2020-09-01

Litteratursökningsdatum: 2020-05-20

Referenser

  1. Frampton JE. Efmoroctocog Alfa: A Review in Haemophilia A. Drugs. 2016;76(13):1281-1291. PubMed
  2. Elocta (efmoroctokog alfa). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2019-07-25, cited 2020-05-20]
  3. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.] länk

Författare: Mia von Euler

Faktagranskat av: Carl-Olav Stiller, Diana Rydberg

Godkänt av: Karin Schenck-Gustafsson