Lesinurad Pregnancy and Breastfeeding Warnings

Brand names: Zurampic

Lesinurad Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned.

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

Comments: In female patients using hormonal contraceptives to prevent pregnancy, concomitant use with this drug may decrease contraceptive reliability; use of adequate methods of non-hormonal contraception should be discussed.

Studies in rabbits and rats have failed to reveal evidence of teratogenicity, effect on fetal development, or survival at doses of 10 times the maximum recommended human dose (MRHD) and 45 times MRHD, respectively; however, maternal toxicity was observed. 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 about 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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Lesinurad Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects in the nursing infant are unknown.

No information exists regarding excretion or effect on milk production in humans. In rats dosed at levels approximately 5 times the maximum recommended human dose from gestation day 7 to lactation day 20, this drug did not affect growth and development of offspring; concentrations in the mothers' plasma and milk were approximately equal.

See references

Further information

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