Difelikefalin Pregnancy and Breastfeeding Warnings

Brand names: Korsuva

Medically reviewed by Drugs.com. Last updated on Oct 19, 2023.

Difelikefalin Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: Use should be avoided.

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

Risk summary: Limited data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-There is no information on the effect of this drug on human fertility.
-In pre-clinical studies, this drug has been shown to cross the placenta in rats.

In animal reproduction studies, this drug was not associated with embryofetal lethality or fetal malformations in rats or rabbits at doses 711 and 10 times the maximum recommended human dose (MRHD), respectively. There were incidences of skeletal variations (wavy ribs and incompletely ossified ribs) in rat pups at a dose estimated to be 711 times the maximum recommended human dose (MRHD). It prolonged diestrus in female rats at doses greater than or equal to 2.5 mg/kg/day (56 times the MRHD based on AUC comparison). In rabbits, maternal toxicity, was reported in all dose groups. In a prenatal and postnatal development study, this drug was administered by intravenous injection to pregnant rats. No effects on postnatal developmental, neurobehavioral, or reproductive performance of offspring were noted at doses up to 282 times the MRHD. 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 healthcare 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.

See references

Difelikefalin Breastfeeding Warnings

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 or on milk production are unknown.
-Drugs present in animal milk are likely to be present in human milk.

This drug was detected in the milk of lactating rats. There was no measurable drug level in the plasma of nursing pups.

See references

Further information

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

Medical Disclaimer