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Glatiramer Pregnancy and Breastfeeding Warnings

Glatiramer is also known as: Copaxone, Glatopa

Medically reviewed on Oct 5, 2018

Glatiramer Pregnancy Warnings

Animal studies failed to reveal teratogenic effects at doses higher than human therapeutic doses. There are no adequate and well-controlled studies in pregnant women.

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.

This drug should only be given during pregnancy when benefit outweighs risk.

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

Comments:
-The manufacturer recommends that women of childbearing potential should use a contraceptive while receiving therapy with this drug.
-The effects of this drug on labor and delivery in pregnant women are unknown.

See references

Glatiramer Breastfeeding Warnings

Caution is recommended.

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

-Data from the manufacturer indicates that after subcutaneous injection, this drug undergoes rapid degradation to amino acids and shorter peptides and that it cannot be detected in the plasma, urine, or feces. Any drug that may reach the breastmilk would probably be destroyed in the infant's gastrointestinal tract and not absorbed, except perhaps in neonates.
-Limited information indicates that maternal use of this drug does not cause any adverse effects in breastfed infants.
-The Multiple Sclerosis Center of Excellence on Reproduction and Child Health considers this drug to be "moderately safe" to use during breastfeeding.

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. Copaxone (glatiramer)." Teva Pharmaceuticals USA, Kulpsville, PA.

References for breastfeeding information

  1. 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 -]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  4. "Product Information. Copaxone (glatiramer)." Teva Pharmaceuticals USA, Kulpsville, PA.

Further information

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

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