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Collagenase clostridium histolyticum Pregnancy and Breastfeeding Warnings

Collagenase clostridium histolyticum is also known as: Xiaflex

Medically reviewed on December 15, 2017

Collagenase clostridium histolyticum Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage.

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.

Benefit should outweigh risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

See references

Collagenase clostridium histolyticum Breastfeeding Warnings

Caution is recommended

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

Comment: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  3. "Product Information. Xiaflex (collagenase clostridium histolyticum)." Auxilium Pharmaceuticals Inc, Norristown, PA.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Xiaflex (collagenase clostridium histolyticum)." Auxilium Pharmaceuticals Inc, Norristown, PA.
  3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

Further information

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

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