Nusinersen Pregnancy and Breastfeeding Warnings

Brand names: Spinraza

Medically reviewed by Drugs.com. Last updated on Sep 12, 2023.

Nusinersen Pregnancy Warnings

Benefit should outweigh risk

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk Summary: There are no adequate data on the developmental risk associated with the use of this drug in pregnant women; in mice, long-term neurobehavioral impairment was observed.

Adverse effects on embryo fetal development were not observed following every other day subcutaneous administration to male and female mice prior to, during mating, and continuing in females through organogenesis. With subcutaneous injection to mice throughout pregnancy and lactation, developmental toxicity was observed at all doses tested. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

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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Nusinersen Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

Further information

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