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Telotristat Pregnancy and Breastfeeding Warnings

Telotristat is also known as: Xermelo

Telotristat Pregnancy Warnings

Animal studies have revealed evidence of post-implantation loss, decreased fetal weight, and an increased incidence of offspring mortality when this drug was given during organogenesis at maternally toxic levels. There are no controlled data in human pregnancy.

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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

See references

Telotristat Breastfeeding Warnings

There are no data regarding the effects of this drug on breastfed infants or milk production.

Benefit to mother should outweigh risk to the infant.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comment: Breastfed infants should be monitored for constipation.

See references

References for pregnancy information

  1. "Product Information. Xermelo (telotristat ethyl)." Lexicon Pharmaceuticals, Inc., The Woodlands, TX.

References for breastfeeding information

  1. "Product Information. Xermelo (telotristat ethyl)." Lexicon Pharmaceuticals, Inc., The Woodlands, TX.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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