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Ivacaftor Pregnancy and Breastfeeding Warnings

Ivacaftor is also known as: Kalydeco

Ivacaftor Pregnancy Warnings

This drug should be used only if clearly needed. AU TGA pregnancy category: B3 US FDA pregnancy category: Not assigned. Risk Summary: Oral administration of this drug to pregnant animals during organogenesis demonstrated no teratogenicity or adverse developmental effects on fetal development at doses that produced maternal exposures up to 3 times the exposure at the maximum recommended human dose (MRHD).

Animal studies have failed to reveal evidence of teratogenicity at high human doses. Placental transfer of this drug was observed. 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 (probable) Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown. A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

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

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