Drug products: Soliris
ATC code: L04AA25
Published studies on differences between men and women regarding efficacy, safety, and pharmacokinetics of eculizumab are lacking.
The present evidence concerning differences between men and women is very limited and does not motivate differentiation in dosing or treatment.
Population pharmacokinetic studies conducted by the original manufacturer in Paroxysmal Nocturnal Hemoglobinuria (PNH) patients found no sex differences in effects of eculizumab pharmacokinetics .
According to the manufacturer’s approval documentation to FDA, no specific studies have been conducted to evaluate the effect of sex differences in the clinical effect of eculizumab in PNH patients . No published studies with a clinically relevant sex analysis regarding the effect of eculizumab have been found.
No published studies with a clinically relevant sex analysis regarding adverse effects of eculizumab have been found.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2017-03-20
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson