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Efmoroctocog alfa

Classification: B

Drug products: ELOCTA

ATC code: B02BD02

Substances: efmoroctocog alfa

Summary

As the substance is almost exclusively used by men, analyses on sex or gender differences have not been considered 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).

Updated: 2020-09-01

Date of litterature search: 2020-05-20

References

  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

Authors: Mia von Euler

Reviewed by: Carl-Olav Stiller, Diana Rydberg

Approved by: Karin Schenck-Gustafsson