THIS MEDICATION CAN CAUSE HARM TO YOUR BABY
What is miglustat?
Miglustat is an enzyme inhibitor that prevents formation of fatty chemicals that cause symptoms of type I Gaucher disease. Type I Gaucher disease is a genetic condition that prevents an important enzyme (that breaks down these fatty chemicals) from being made. Enzyme replacement therapy can supplement the lack of enzyme produced by the body in some patients.
What is miglustat used to treat?
Miglustat is a prescription medication used to treat the genetic condition known as type I Gaucher disease, specifically in patients who cannot take enzyme replacement therapy.
How does miglustat work?
Miglustat inhibits an enzyme that produces a fatty chemical in the body; the build-up of this fatty chemical throughout the body causes type I Gaucher disease symptoms. Type I Gaucher disease is characterized by an enlarged liver or spleen, low red blood cell and platelet counts, chronic fatigue, and lung or bone disease.
If I am taking miglustat, can it harm my baby?
Studies in humans are limited. Animal studies showed decreased weight and a reduced chance of survival of the baby. Miglustat is expected to cross the placenta to reach the baby. The use of miglustat during pregnancy is contraindicated. Women with uncontrolled type I Gaucher disease who become pregnant have an increased risk of spontaneous abortion as well as harm to themselves and the developing baby.
If I am taking miglustat and become pregnant, what should I do?
It is important to speak with your doctor immediately if you are taking miglustat and become pregnant. There is limited safety information in pregnant women; therefore, miglustat is contraindicated in pregnancy.
If I am taking miglustat, can I safely breastfeed my baby?
Information in humans is lacking, but miglustat is expected to be excreted in the breast milk. It is generally recommended to either discontinue bmiglustat or discontinue breastfeeding if remaining on miglustat.
If I am taking miglustat, will it be more difficult to get pregnant?
Information on fertility effects in humans is lacking. In animal studies, there was a decrease in male sperm development; however, a study in 7 humans males found no effect of miglustat on sperm development.
If I am taking miglustat, what should I know?
It is important to speak with your doctor to determine if you should continue miglustat therapy during pregnancy. Human studies are lacking. Miglustat is commonly contraindicated in pregnancy because of a lack of safety information in pregnant women. Uncontrolled type I Gaucher disease is also associated with serious side effects in both mother and baby.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of Zavesca during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert report about gaucher disease here and reports about the individual medications used to treat this and other conditions here. Additional information can also be found in the resources below.
For more information about miglustat during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following links: