Idursulfase Pregnancy and Breastfeeding Warnings

Brand names: Elaprase

Medically reviewed by Drugs.com. Last updated on Nov 25, 2024.

Idursulfase Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: This drug should be used during pregnancy only if clearly needed.
-According to some authorities: Use should be avoided.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Risk summary: Inadequate data available on the use of this drug in pregnant women to inform a drug-related risk.

Animal studies have failed to reveal evidence of adverse effects on pre- and postnatal development at doses up to 12.5 mg/kg IV administered twice a week (about 4 times the recommended human weekly dose of 0.5 mg/kg based on body surface area). Teratogenicity studies have not been conducted. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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

Idursulfase Breastfeeding Warnings

AU and UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
US: Caution is recommended.

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

Comments: The effects in the nursing infant are unknown.

There is no information available on the clinical use during breastfeeding. Since this drug is a large protein molecule, the amount in milk is likely very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract.

See references

Further information

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