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Taliglucerase alfa Pregnancy and Breastfeeding Warnings

Taliglucerase alfa is also known as: Elelyso

Taliglucerase alfa Pregnancy Warnings

Caution is recommended; benefit should outweigh risk. AU TGA pregnancy category: B1 US FDA pregnancy category: Not assigned. Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk. Comments: Maternal and embryo/fetal risk due to the mother's underlying condition should be considered.

Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Increased risk of spontaneous abortion in women with type 1 Gaucher disease, especially if disease symptoms are not treated and controlled before conception and during pregnancy. Type 1 Gaucher disease symptoms may worsen or new symptoms may develop due to pregnancy. Such symptoms may lead to adverse pregnancy outcomes. AU TGA pregnancy category B1: 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 have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Taliglucerase alfa Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown Comments: -To avoid excessive bone loss in the nursing mother, limiting the duration of breastfeeding to about 6 months should be considered. -This drug is a large protein molecule (molecular weight about 61,000); the amount in milk is likely to be very low; absorption unlikely as it is probably destroyed in the infant gastrointestinal tract. -Similar agents (alglucerase and imiglucerase) have been used without apparent harmful effects in the nursing infant.

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References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Elelyso (taliglucerase alfa)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

References for breastfeeding information

  1. "Product Information. Elelyso (taliglucerase alfa)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. 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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