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Ivacaftor Pregnancy and Breastfeeding Warnings

Ivacaftor is also known as: Kalydeco

Medically reviewed on Sep 24, 2018

Ivacaftor Pregnancy Warnings

Benefit should outweigh risk; this drug should be used only if clearly needed

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; studies in rats and rabbits have demonstrated no teratogenicity or adverse effects on fetal development at doses that produced maternal exposures up to approximately 5 (rats) and 11 (rabbits) times exposure at maximum recommended human doses (MRHD).

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

Lacteal excretion of this drug was observed following a single radiolabel oral dose administered 9 to 10 days postpartum to lactating rats. Exposure was approximately 1.5 times higher than plasma levels.

Benefit should outweigh risk

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

Comments:
-The effects in the nursing infant are unknown.
-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.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  3. "Product Information. Kalydeco (ivacaftor)." Vertex Pharmaceuticals, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Kalydeco (ivacaftor)." Vertex Pharmaceuticals, Cambridge, MA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

Further information

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

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