Miglustat Pregnancy and Breast Feeding Warnings

Miglustat is also known as: Zavesca

Overview

Miglustat may cause harm to the fetus. Do not use Miglustat if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. Avoid becoming pregnant while taking Miglustat . It is unknown if Miglustat is excreted in breast milk. Do not breast-feed while taking Miglustat .

Miglustat Pregnancy Warnings

Miglustat has been assigned to pregnancy category X by the FDA. Animal studies have revealed evidence of fetal harm, maternal death, and impaired fertility by adversely affecting spermatogenesis and sperm parameters. There are no controlled data in human pregnancy. Miglustat is considered contraindicated in women who are or may become pregnant.

If miglustat is administered to a woman with reproductive potential, the patient should be apprised of the potential hazard to the fetus. Male patients should maintain reliable contraceptive methods during therapy with miglustat and for 3 months after stopping therapy.

Miglustat Lactation Warnings

There are no data on the excretion of miglustat into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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