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Eculizumab

Classification: B

Drug products: Soliris

ATC code: L04AA25

Substances: eculizumab

Summary

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.

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 the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Updated: 2019-02-26

Date of litterature search: 2017-03-20

References

  1. Food and Drug Aministration (FDA). Clinical Pharmacology and Biopharmaceutics Review - SOLIRIS (eculizumab). Food and Drug Administration [www]. [updated 2007-05-17, cited 2017-03-20]. länk
  2. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2016 [cited 2017-03-23.] länk

Authors: Linnéa Karlsson Lind

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson