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Imiglucerase Pregnancy and Breastfeeding Warnings

Imiglucerase is also known as: Cerezyme

Imiglucerase Pregnancy Warnings

Animal studies have not been reported. Limited data from 150 pregnancy outcomes (primarily based on spontaneous reports and literature review) suggests use of this drug is beneficial to control underlying Gaucher disease in pregnancy. No data available to indicate malformative toxicity to the fetus. Patients with Gaucher disease who become pregnant may experience a period of increased disease activity during pregnancy and the puerperium, including an increased risk of skeletal manifestations, exacerbation of cytopenia, hemorrhage, and an increased need for transfusion. There are no controlled data in human pregnancy. 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 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.

Use is not recommended unless clearly needed and the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B2 US FDA pregnancy category: C Comments: -Treatment naive women should consider beginning therapy prior to conception to attain optimal health and to consider continuing treatment throughout pregnancy. -Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualization of dose per the patient's needs and therapeutic response.

See references

Imiglucerase Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Absorption by the infant is unlikely because this drug is probably destroyed in the infant's gastrointestinal tract. -Consider limiting duration of breastfeeding to about 6 months to avoid excessive bone loss in the nursing mother.

An international panel of clinicians from 9 centers determined that breastfeeding complications were less frequent in mothers treated with this drug postpartum than in untreated mothers with Gaucher's disease.

See references

References for pregnancy information

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

References for breastfeeding information

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

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