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Turoctocog alfa

Classification: B

Drug products: NovoEight

ATC code: B02BD02

Substances: turoctocog alfa

Summary

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

Additional information

Tuructocog alfa is a factor VIII concentrate product used in treatment of acute bleeding episodes, perioperative management and routine prophylaxis patients with 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 tuructocog alfa have been found.

Effects

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

Adverse effects

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

Reproductive health issues

No studies with a clinically relevant analysis regarding fertility or reproduction of tuructocog 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. Vakil NH, Fujinami N, Martin-Stone S. Turoctocog alfa for the treatment of hemophilia a. Pharmacotherapy. 2014;34(10):1091-101. PubMed
  2. NovoEight (turoctocog alfa). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2020-03-12, 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