Elexacaftor / ivacaftor / tezacaftor Pregnancy and Breastfeeding Warnings

Brand names: Trikafta

Medically reviewed by Drugs.com. Last updated on Dec 1, 2023.

Elexacaftor / ivacaftor / tezacaftor Pregnancy Warnings

Benefit should outweigh risk.
-According to some authorities: Use should be avoided as a precautionary measure.

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

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

Animal studies conducted separately for each active component of this drug have failed to reveal evidence of teratogenicity or adverse developmental effects at doses up to 14 times the maximum recommended human dose (MRHD). Decreased fetal body weights were observed at maternally toxic doses (1 to 5 times the MRHD). Placental transfer has been observed in pregnant rats and rabbits. Impaired fertility in both male and female animals was observed at doses greater than 6 times the MRHD. There are no animal reproduction studies with the concomitant administration of elexacaftor, tezacaftor, and ivacaftor. 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.

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Elexacaftor / ivacaftor / tezacaftor Breastfeeding Warnings

Benefit should outweigh risk.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and benefit of breastfeeding for the child.

Excreted into human milk: Yes (elexacaftor, ivacaftor, and tezacaftor)

Comments:
-Until more data are available, consider monitoring infant bilirubin and liver enzymes during breastfeeding, and examining breastfed infants for cataracts.
-A task force of respiratory experts have found that this combination drug is probably safe during breastfeeding.
-An international survey of cystic fibrosis centers reportedly found no adverse effects in the breastfed infants of mothers taking this combination product.
-When determining 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.

Data from maternal-infant pairs indicate that each active component of the combination product (elexacaftor, ivacaftor, and tezacaftor) was detected in small amounts in maternal milk and infant serum. Lacteal excretion has been demonstrated in animal studies.

Elevated bilirubin and liver enzymes were reported in a breastfed infant exposed to ivacaftor (in combination with lumacaftor); however, it was noted that these abnormal results could not be definitively attributed to drug exposure.

Cataracts in infants exposed to this combination drug during pregnancy and breastfeeding have been described in case reports; however, the contribution of breastfeeding to the cataracts could not be determined.

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Further information

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