Eculizumab
Classification: BATC code: L04AA25
Summary
Published studies on differences between men and women regarding efficacy, safety, and pharmacokinetics of eculizumab are lacking.
Additional information
Pharmacokinetics and dosing
Population pharmacokinetic studies conducted by the original manufacturer in Paroxysmal Nocturnal Hemoglobinuria (PNH) patients found no sex differences in effects of eculizumab pharmacokinetics [1].
Effects
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 [1]. No published studies with a clinically relevant sex analysis regarding the effect of eculizumab have been found.
Adverse effects
No published studies with a clinically relevant sex analysis regarding adverse effects of eculizumab have been found.
Reproductive health issues
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Updated: 2020-08-28
Date of litterature search: 2017-03-20
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson