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Eliglustat Pregnancy and Breastfeeding Warnings

Eliglustat is also known as: Cerdelga

Medically reviewed on September 19, 2017

Eliglustat Pregnancy Warnings

In rats, doses about 6 times the recommended human dose increased the number of late resorptions, dead fetuses and post implantation loss, reduced fetal body weight, and caused fetal cerebral variations (dilated cerebral ventricles), fetal skeletal variations (poor bone ossification) and fetal malformations (abnormal number of ribs or lumbar vertebra). However, no fetal harm was observed with oral administration of eliglustat to pregnant rabbits at dose levels 10 times the recommended human dose. There are no controlled data in human pregnancy

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

See references

Eliglustat Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

See references

References for pregnancy information

  1. "Product Information. Cerdelga (eliglustat)." Genzyme Corporation, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Cerdelga (eliglustat)." Genzyme Corporation, Cambridge, MA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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