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Damoctocog alfa pegol

Classification: B

Drug products: Jivi

ATC code: B02BD02

Substances: damoctocog alfa pegol

Summary

Published controlled studies on differences between men and women regarding efficacy, safety and pharmacokinetics of damoctocog alfa pegol are lacking.

Additional information

Damoctocog alfa pegol is a pegylated recombinant factor VIII product used in treatment of acute bleeding episodes, perioperative management and routine prophylaxis in previously treated 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 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 [1].

Pharmacokinetics and dosing

No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of damoctocog alfa pegol have been found.

Effects

No studies with a clinically relevant sex analysis regarding the efficacy of damoctocog alfa pegol have been found.

Adverse effects

No studies with a clinically relevant sex analysis regarding the safety of damoctocog alfa pegol have been found.

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Updated: 2021-06-07

Date of litterature search: 2021-05-25

References

  1. Jivi (damoctocog alfa pegol). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2018-11-22, cited 2021-05-25]
  2. Mehta P and Reddivari AKR. Hemophilia, in StatPearls. Treasure Island (FL): StatPearls Publishing; 2021.
  3. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.] länk

Authors: Therese Wennersten, Linnéa Karlsson Lind

Reviewed by: Diana Rydberg

Approved by: Karin Schenck-Gustafsson