Skip to Content
To SMA parents, advice for you >

Nusinersen Pregnancy and Breastfeeding Warnings

Nusinersen is also known as: Spinraza

Medically reviewed on April 28, 2017.

Nusinersen Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.

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.

when this drug was administered subcutaneously to males and females every other day prior to and during mating and continuing in females throughout organogenesis. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity 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

Nusinersen Breastfeeding Warnings

Benefit should outweigh risk.

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

-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Spinraza (nusinersen)." Biogen Idec Inc, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Spinraza (nusinersen)." Biogen Idec Inc, Cambridge, MA.

Further information

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