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Asfotase alfa Pregnancy and Breastfeeding Warnings

Asfotase alfa is also known as: Strensiq

Asfotase alfa Pregnancy Warnings

In animal studies in rats and rabbits, IV use during the period of organogenesis showed no evidence of fetotoxicity, embryolethality, or teratogenicity at doses of 21 and 24 times the recommended human exposure dose, respectively. Following subcutaneous administration in pregnant mice, cross-placental transfer of drug was observed. There are no data in pregnant women. 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.

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. Comments: This drug is not recommended in the UK for use during pregnancy or in women of childbearing potential not using contraception.

See references

Asfotase alfa Breastfeeding Warnings

There are no data on the presence of this drug in breast milk, the effects on the breastfed infant, or the effects on milk production.

US: Use caution UK: Breastfeeding should be discontinued Excreted into human milk: Unknown Excreted into animal milk: Data not available Comment: The effects in the nursing infant are unknown.

See references

References for pregnancy information

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

References for breastfeeding information

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

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