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Eluxadoline Pregnancy and Breastfeeding Warnings

Eluxadoline is also known as: Viberzi

Eluxadoline Pregnancy Warnings

In animal studies, no teratogenicity was demonstrated in rats and rabbits with combined oral and subcutaneous administration during organogenesis at doses approximately 51 (rat) and 115 (rabbit) times human exposure. Pre and postnatal development studies have demonstrated no adverse effects in rat offspring with oral administration at doses approximately 10 times human exposure. 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 decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Benefit should outweigh risk 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

Eluxadoline Breastfeeding Warnings

Benefit should outweigh risk Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

In rats administered oral doses of 1.8, 3, and 10 times human exposure, mean concentrations on lactation day 12 were 2.78, 5.49, and 44.02 ng/mL, respectively. There is no data on the presence of this drug in human milk, the effects on the breastfed infant, or the effect on milk production. In deciding whether or not to breastfeed, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for treatment and any potential adverse effects that could occur from treatment or the mother's underlying condition.

See references

References for pregnancy information

  1. "Product Information. Viberzi (eluxadoline)." Actavis Pharma, Inc., Parsippany, NJ.

References for breastfeeding information

  1. "Product Information. Viberzi (eluxadoline)." Actavis Pharma, Inc., Parsippany, NJ.

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