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Pegloticase Pregnancy and Breastfeeding Warnings

Pegloticase is also known as: Krystexxa

Pegloticase Pregnancy Warnings

This drug was not teratogenic in rats and rabbits at doses of 50 and 75 times the maximum recommended human dose (MRHD), respectively, while statistically significant decreases in pup weight were observed. At dose of 10 and 25 times MHRD, no effects on mean fetal body weights were observed, respectively. There are adequate and well-controlled studies in pregnant women. 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.

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

See references

Pegloticase Breastfeeding Warnings

Use is not recommended unless clear benefit to the mother outweighs the unknown risk to the infant Excreted into human milk: Unknown Excreted into animal milk: Data not available The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Krystexxa (pegloticase)." Savient Pharmaceuticals, East Brunswick, NJ.

References for breastfeeding information

  1. "Product Information. Krystexxa (pegloticase)." Savient Pharmaceuticals, East Brunswick, NJ.

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