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Taliglucerase alfa Pregnancy and Breastfeeding Warnings

Taliglucerase alfa is also known as: Elelyso

Medically reviewed by Drugs.com. Last updated on Nov 7, 2019.

Taliglucerase alfa Pregnancy Warnings

Caution is recommended; benefit should outweigh risk

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk Summary: Limited data on use of this drug in pregnant women is insufficient to inform a drug-associated risk; there are disease-associated maternal and/or embryo/fetal risks due to mother's underlying condition.

Comments: Pregnancy may exacerbate existing type 1 Gaucher disease symptoms or result in new disease manifestations.

Animal studies have failed to reveal evidence of embryo-fetal toxicity with doses 5 times the recommended human dose. An increased risk of spontaneous abortion has been observed in women with Type 1 Gaucher's disease, especially if disease symptoms are not treated and controlled before conception and during pregnancy. Disease manifestations that may lead to adverse pregnancy outcomes, include hepatosplenomegaly which can interfere with the normal growth of a fetus and thrombocytopenia which can lead to increased bleeding and possible postpartum hemorrhage requiring transfusion. There are no controlled data in human pregnancy.

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.

See references

Taliglucerase alfa Breastfeeding Warnings

There is no information on the use of this drug during breastfeeding. It is a large protein molecule (molecular weight about 61,000) and therefore the amount in milk is likely to be very low and infant absorption unlikely. Among mothers with Gaucher's disease, breastfeeding complications have been observed less frequently in mothers treated with alglucerase or imiglucerase (other biosynthetic forms of the enzyme) postpartum than in mothers with Gaucher's disease who were not receiving treatment for Gaucher's disease.

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-To avoid excessive bone loss in the nursing mother, consider limiting breastfeeding to about 6 months.

See references

References for pregnancy information

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

References for breastfeeding information

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

Further information

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