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Sebelipase alfa Pregnancy and Breastfeeding Warnings

Sebelipase alfa is also known as: Kanuma

Medically reviewed on June 25, 2018

Sebelipase alfa Pregnancy Warnings

Safety has not been established during pregnancy; according to some experts, use should be avoided.

AU TGA pregnancy category: B1
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 failed to reveal evidence of embryolethality, fetotoxicity, teratogenicity, or abnormal early embryonic development at higher doses. 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.

See references

Sebelipase alfa Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Kanuma (sebelipase alfa)." Alexion Pharmaceuticals Inc, Cheshire, CT.

References for breastfeeding information

  1. "Product Information. Kanuma (sebelipase alfa)." Alexion Pharmaceuticals Inc, Cheshire, CT.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

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