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Idursulfase Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Nov 24, 2021.

Idursulfase is also known as: Elaprase

Idursulfase Pregnancy Warnings

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

UK: Use should be avoided.
AU and US: This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

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

References for pregnancy information

  1. "Product Information. Elaprase (idursulfase)." Shire US Inc, Florence, KY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Elaprase (idursulfase)." Shire US Inc, Florence, KY.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

Further information

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