Istradefylline Pregnancy and Breastfeeding Warnings

Brand names: Nourianz

Medically reviewed by Drugs.com. Last updated on Sep 25, 2023.

Istradefylline Pregnancy Warnings

Use is not recommended

US FDA pregnancy category: Not assigned

Risk Summary: There is no data on the developmental risk associated with use in pregnant women; in animal studies, teratogenicity was observed at clinically relevant exposures.

Comments:
-Women of childbearing potential should be advised to use contraception during treatment.

Administration of this drug in combination with levodopa/carbidopa to pregnant rabbits during organogenesis resulted in increased embryofetal mortality and increased malformations, particularly at high doses (limb reduction, craniofacial, and cardiovascular); administration of this drug alone resulted in increased embryofetal mortality and visceral malformations. In rats, decreased fetal weights and increased fetal skeletal and visceral variations were observed at the highest doses tested. Effects in animals were observed at clinically relevant exposures in the absence of maternal toxicity. The teratogenic effects in pregnant rabbits were substantially greater when administered with levodopa/carbidopa. 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.

See references

Istradefylline Breastfeeding Warnings

Benefit should outweigh risk

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

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

This drug is present in the milk of lactating rats at concentrations up to 10 times that in maternal plasma.

See references

Further information

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