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Rasburicase Pregnancy and Breastfeeding Warnings

Rasburicase is also known as: Elitek, Fasturtec

Rasburicase Pregnancy Warnings

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. AU TGA pregnancy category: B2 US FDA pregnancy category: C

Teratogenicity was observed in rabbits treated with 10 to 100 times the recommended human dose (RHD) during organogenesis and in rats given 250 times RHD . Pregnant rabbits treated at all dose levels experienced pre and post implantation losses, abortions, and decreased uterine weights. It is unknown if this drug crosses the placental barrier in humans. 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.

See references

Rasburicase Breastfeeding Warnings

There are no data on the excretion into human milk and no information on the clinical use of this drug during breastfeeding. As this drug is a large protein molecule, a very low amount is expected to be excreted into milk and subsequent absorption is unlikely because it will presumably be destroyed in the infant's gastrointestinal tract. But serious adverse reactions have occurred with use of this drug and these risks should be considered as possible in nursing infants.

A decision should be made to discontinue nursing or discontinue this drug, taking into account the importance of the drug to the mother 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. "Product Information. Elitek (rasburicase)." Sanofi Winthrop Pharmaceuticals, New York, NY.
  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. 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. "Australian Product Information." O 0
  3. "Product Information. Elitek (rasburicase)." Sanofi Winthrop Pharmaceuticals, New York, NY.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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