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Cerliponase alfa Pregnancy and Breastfeeding Warnings

Cerliponase alfa is also known as: Brineura

Medically reviewed by Drugs.com. Last updated on Jan 28, 2019.

Cerliponase alfa Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk summary: There are 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

Benefit should outweigh risk

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

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

References for pregnancy information

  1. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
  2. "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.
  2. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

Further information

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

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