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Ivacaftor / lumacaftor Pregnancy and Breastfeeding Warnings

Ivacaftor / lumacaftor is also known as: Orkambi

Medically reviewed on November 10, 2016

Ivacaftor / lumacaftor Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity at high human doses. Decreased fetal body weights in animals were observed at doses of ivacaftor that produced maternal toxicity. Treatment with lumacaftor demonstrated a slight increase in incidence of minor skeletal abnormalities in rabbits at doses that also produced maternal toxicity. 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.

This drug should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus.

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

Risk Summary: Limited and incomplete data on use of this drug or its individual components in pregnant women to inform a drug-related risk.

-May decrease hormonal contraceptive exposure thus reducing the effectiveness.
-Hormonal contraceptives (including oral, injectable, transdermal, and implantable) should not be relied upon as an effective method of contraception when coadministered with this drug.

See references

Ivacaftor / lumacaftor Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown (ivacaftor, lumacaftor)
Excreted into animal milk: Yes (ivacaftor, lumacaftor)

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Orkambi (ivacaftor-lumacaftor)." Vertex Pharmaceuticals, Cambridge, MA.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Orkambi (ivacaftor-lumacaftor)." Vertex Pharmaceuticals, Cambridge, MA.

Further information

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