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Teduglutide Pregnancy and Breastfeeding Warnings

Teduglutide is also known as: Gattex

Teduglutide Pregnancy Warnings

Use is not recommended unless clearly needed. AU TGA pregnancy category: B1 US FDA pregnancy category: B

Animal models 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. 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 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

The highest drug concentration measured in expressed milk of animal models 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. -Some experts recommend: Use should be avoided. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -The effects in the nursing infant are unknown. -Use may be associated with a potential for tumorigenicity in animal models.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Gattex (teduglutide)." NPS Pharmaceuticals, Bedminster, NJ.

References for breastfeeding information

  1. "Product Information. Gattex (teduglutide)." NPS Pharmaceuticals, Bedminster, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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