Ivacaftor Pregnancy and Breastfeeding Warnings

Brand names: Kalydeco

Medically reviewed by Drugs.com. Last updated on Aug 21, 2023.

Ivacaftor Pregnancy Warnings

Benefit should outweigh risk
-Some authorities recommend avoiding during pregnancy as a precautionary measure.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: There is limited and incomplete data on use of this drug in pregnant women.

Comments:
-Due to limited experience, this drug should be used only if clearly needed and the expected benefit to the mother justifies the potential risks to the fetus.

Animal studies have failed to reveal evidence of teratogenicity at doses up to 11 times the MRHD. Decreased fetal body weight was observed at a maternally toxic dose (5 times the MRHD). Placental transfer has been observed in pregnant rats and rabbits. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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

Ivacaftor Breastfeeding Warnings

Benefit should outweigh risk

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

Comments:
-If used during breastfeeding, consider monitoring infant liver enzymes and bilirubin, and examining infant for cataracts.
-When considering benefit and risk, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug, and potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.
-Some authorities advise against breastfeeding until more data is available.

See references

Further information

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