Asfotase alfa Pregnancy and Breastfeeding Warnings

Brand names: Strensiq

Medically reviewed by Drugs.com. Last updated on Jul 5, 2023.

Asfotase alfa Pregnancy Warnings

Safety has not been established during pregnancy

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk summary: No available data in pregnant women to inform a drug-associated risk.

Comments: Some authorities recommend against use in women of childbearing potential not using contraception.

In animal studies in rats and rabbits, IV use during the period of organogenesis showed no adverse effects on embryofetal development with doses of 21 and 24 times the recommended human exposure dose, respectively. No evidence of pre- and post-natal development adverse effects were observed in rats. Following subcutaneous administration in pregnant mice, cross-placental transfer of drug was observed. There are no data in pregnant women.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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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Asfotase alfa Breastfeeding Warnings

Benefit should outweigh risk

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

Comment: The effects in the nursing infant are unknown.

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. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug or any potential adverse effects on the breastfed infant. Some authorities advise against breastfeeding as a risk to the breastfed infant cannot be excluded.

See references

Further information

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