Ivacaftor / lumacaftor Pregnancy and Breastfeeding Warnings

Brand names: Orkambi

Medically reviewed by Drugs.com. Last updated on Aug 22, 2023.

Ivacaftor / lumacaftor Pregnancy Warnings

Benefit should outweigh risk.

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

Risk summary: There are limited and incomplete data on the use of this drug or its components (ivacaftor, lumacaftor) in pregnant women to inform a drug-associated risk.

Comments:
-Hormonal contraceptives (including oral, injectable, transdermal, and implantable) should not be relied upon as effective methods of contraception when coadministered with this drug.
-Concomitant use of this drug with hormonal contraceptives may reduce contraceptive exposure, thereby decreasing effectiveness.

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 the 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 using any of the drugs, alone or in combination, 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 / lumacaftor Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Yes (ivacaftor, lumacaftor)

Comments:
-If used during breastfeeding, consider monitoring infant liver enzymes and bilirubin, and examining for cataracts.
-A task force of international respiratory experts concluded that this drug is probably safe during breastfeeding.
-When assessing benefit versus risk, consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this drug against any potential adverse effects on the breastfed child from this drug or from the underlying maternal condition.

See references

Further information

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