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Teduglutide Pregnancy and Breastfeeding Warnings

Teduglutide is also known as: Gattex

Teduglutide Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed. US FDA pregnancy category: B

Animal studies have failed to reveal any adverse effects on embryo-fetal development, pre- and post-natal development, fertility, and reproductive performance at doses up to 1000 times the recommended human dose. There are no controlled data in human pregnancy. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Teduglutide Breastfeeding Warnings

This drug is excreted in the milk of lactating rats. The highest drug concentration measured in rat milk was 2.9% of the maternal plasma concentration following a single subcutaneous injection of 25 mg/kg.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Gattex (teduglutide)." NPS Pharmaceuticals, Bedminster, NJ.

References for breastfeeding information

  1. "Product Information. Gattex (teduglutide)." NPS Pharmaceuticals, Bedminster, NJ.

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