Teduglutide Pregnancy and Breastfeeding Warnings

Brand names: Gattex

Medically reviewed by Drugs.com. Last updated on Jan 12, 2024.

Teduglutide Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned.

Risk Summary: Malformative risk with use of this drug in pregnant women is unlikely. Malformation caused by short bowel syndrome may be associated with adverse effects on embryofetal development.

Comment: Some experts state that use should be avoided during pregnancy.

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 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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Teduglutide Breastfeeding Warnings

Use is not recommended and 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:
-Some experts recommend that use should be avoided.
-The effects in the nursing infant are unknown.
-Use may be associated with a potential for tumorigenicity in animal models.

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.

See references

Further information

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