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Agalsidase beta Pregnancy and Breastfeeding Warnings

Agalsidase beta is also known as: Fabrazyme

Medically reviewed on Jan 29, 2018

Agalsidase beta Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm or impaired fertility. There are no controlled data in human pregnancy.

Women of childbearing potential are encouraged to register themselves in the Fabry patient registry in order to monitor the effects on pregnant women and their offspring. For additional information: fabryregistry.com

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B2
US FDA pregnancy category: B

See references

Agalsidase beta Breastfeeding Warnings

Caution is recommended; according to some experts, use is not recommended.

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

Comments: The effects in the nursing infant are unknown.

There is no information available on the clinical use during breastfeeding. Since this drug is a large protein molecule, the amount in milk is likely very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract.

Nursing mothers are encouraged to register themselves in the Fabry registry. For additional information: fabryregistry.com

See references

References for pregnancy information

  1. "Product Information. Fabrazyme (agalsidase beta)." Genzyme Corporation, Cambridge, MA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Fabrazyme (agalsidase beta)." Genzyme Corporation, Cambridge, MA.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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