Eplontersen Pregnancy and Breastfeeding Warnings

Brand names: Wainua

Eplontersen Pregnancy Warnings

Safety has not been established.

US FDA pregnancy category: Not assigned

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Treatment with this drug may decrease serum vitamin A levels, which may impair normal embryofetal development.
-Patients taking this drug should be advised to take vitamin A supplements; however, the effect of such supplementation on the fetus in this setting is unknown.
-Higher doses than the recommended daily allowance of vitamin A should be avoided, as excessive levels of vitamin A are associated with adverse developmental effects.

Animal studies have failed to reveal evidence of embryofetal toxicity. There are no controlled data in human pregnancy.

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

Eplontersen Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant or on milk production are unknown.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-Potential side effects on the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

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

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