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Sebelipase alfa Pregnancy and Breastfeeding Warnings

Sebelipase alfa is also known as: Kanuma

Sebelipase alfa Pregnancy Warnings

Safety has not been established during pregnancy; according to some experts, use should be avoided. 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; no harmful effects on offspring development observed in rats and rabbits at doses up to 164 and 526 times the human dose of 1 mg/kg IV every other week (based on AUC), respectively. 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.

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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

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