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Cerliponase alfa Pregnancy and Breastfeeding Warnings

Cerliponase alfa is also known as: Brineura

Medically reviewed on July 25, 2017

Cerliponase alfa Pregnancy Warnings

Safety has not been established during pregnancy.

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.

Animal studies have not been reported. 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

Cerliponase alfa Breastfeeding Warnings

Safety has not been established.

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

Comments:
-The effects in the nursing infant 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 in the breastfed child due to the drug or the mother's underlying condition should be considered.

See references

References for pregnancy information

  1. "Product Information. Brineura (cerliponase alfa)." BioMarin Pharmaceutical Inc, Novato, CA.

References for breastfeeding information

  1. "Product Information. Brineura (cerliponase alfa)." BioMarin Pharmaceutical Inc, Novato, CA.

Further information

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

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