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Galsulfase Pregnancy and Breastfeeding Warnings

Galsulfase is also known as: Naglazyme

Galsulfase Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm, teratogenicity, or impaired fertility. Pregnant rabbits received this drug at estimated exposures of 3-fold or greater than the anticipated clinical exposure and experienced an increased incidence of sternal centra fusion in the absence of significant maternal toxicity; the clinical relevance of this is uncertain. There are no controlled data in human pregnancy.

Pregnant women are encouraged to register themselves in the MPS VI Clinical Surveillance Program. For additional information: 1-800-983-4587 (US).

AU TGA pregnancy category B3: 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 have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is recommended only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: B

See references

Galsulfase Breastfeeding Warnings

Caution is recommended; according to some experts, use is not recommended.

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

Comments: The effects in the nursing infant are unknown.

Nursing mothers are encouraged to register themselves in the MPS VI Clinical Surveillance Program. For additional information: 1-800-983-4587 (US).

See references

References for pregnancy information

  1. "Product Information. Naglazyme (galsulfase)." BioMarin Pharmaceutical Inc, Novato, CA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
  3. "Product Information. Naglazyme (galsulfase)." BioMarin Pharmaceutical Inc, Novato, CA.

Further information

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

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