Drug products: Jivi
ATC code: B02BD02
Substances: damoctocog alfa pegol
Published controlled studies on differences between men and women regarding efficacy, safety and pharmacokinetics of damoctocog alfa pegol are lacking.
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 . 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) . The occurrence of hemophilia A in women is very rare and data in women is not available .
No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of damoctocog alfa pegol have been found.
No studies with a clinically relevant sex analysis regarding the efficacy of damoctocog alfa pegol have been found.
No studies with a clinically relevant sex analysis regarding the safety of damoctocog alfa pegol have been found.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2021-05-25
Reviewed by: Diana Rydberg
Approved by: Karin Schenck-Gustafsson