Rasburicase Pregnancy and Breastfeeding Warnings

Brand names: Elitek, Fasturtec

Medically reviewed by Drugs.com. Last updated on Jan 20, 2025.

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: Not assigned.

Risk summary: Based on its mechanism of action and effects in pregnant patients and animals, this drug can cause fetal harm when administered to a pregnant patient; exposure in animal studies during pregnancy resulted in fetal malformations, fetal growth alterations, and toxic effects in the newborn.

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 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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Rasburicase Breastfeeding Warnings

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.

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.

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Further information

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