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Laronidase Pregnancy and Breastfeeding Warnings

Laronidase is also known as: Aldurazyme

Laronidase Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed. AU TGA pregnancy category: B2 US FDA pregnancy category: B

Animal studies have failed to reveal evidence of fetal harm or impaired fertility. There are no controlled data in human pregnancy. Pregnant women are encouraged to register themselves in the MPS I registry. For additional information: MPSIregistry.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.

See references

Laronidase Breastfeeding Warnings

Nursing mothers are encouraged to register themselves in the MPS I registry. For additional information: MPSIregistry.com

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.

See references

References for pregnancy information

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

References for breastfeeding information

  1. 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 -]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Aldurazyme (laronidase)." Genzyme Corporation, Cambridge, MA.

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