Eculizumab

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).