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Agalsidase beta Pregnancy and Breastfeeding Warnings

Agalsidase beta is also known as: Fabrazyme

Medically reviewed by Drugs.com. Last updated on Feb 1, 2019.

Agalsidase beta Pregnancy Warnings

Rats dosed with this drug at up to 68 times the recommended human dose during gestation days 7 to 17 showed no adverse effects on embryofetal development. There are no controlled data in human pregnancy.

Women of childbearing potential are encouraged to register themselves in the Fabry patient registry in order to monitor the effects on pregnant women and their offspring. For additional information: www.registrynxt.com

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.

Benefit should outweigh risk

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

Risk Summary: Available data from postmarketing case reports and case series have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; animal studies have not shown evidence of adverse effects on embryofetal development.

Comments:
-Pregnant women and women of reproductive potential should be encouraged to enroll in the Fabry patient registry; this registry monitors the effect of this drug on pregnant women and their offspring. For information, visit www.registrynxt.com or call 1-800-745-4447, extension 15500.

See references

Agalsidase beta Breastfeeding Warnings

Benefit should outweigh risk

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

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.

Because 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. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition. Nursing mothers are encouraged to register themselves in the Fabry registry; for additional information see www.registrynxt.com

See references

References for pregnancy information

  1. "Product Information. Fabrazyme (agalsidase beta)." Genzyme Corporation, Cambridge, MA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Fabrazyme (agalsidase beta)." Genzyme Corporation, Cambridge, MA.

Further information

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

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