Skip to Content

Natalizumab Pregnancy and Breastfeeding Warnings

Natalizumab is also known as: Tysabri

Natalizumab Pregnancy Warnings

Studies in animals have shown reduced pup survival and adverse hematologic effects on the fetus in doses higher than comparable human doses. Animal studies have not shown teratogenicity. There are no controlled data in human pregnancy. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. 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.

This drug should be used during pregnancy only if clearly needed. AU TGA pregnancy category: C US FDA pregnancy category: C Comment: -If a woman becomes pregnant while taking this drug, discontinuation of therapy should be considered.

See references

Natalizumab Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Comment: -The effects in the nursing infant are unknown.

One case indicates that this drug is excreted into breastmilk in increasing amounts over several weeks after initiation of therapy. The actual time of the peak level is unknown, but might be as long as 6 months. Because this drug is a large protein molecule, absorption is unlikely because it is probably destroyed in the infant GI tract.

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. Tysabri (natalizumab)." Elan Pharmaceutical/Athena Neurosciences Inc, South San Francisco, CA.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Tysabri (natalizumab)." Elan Pharmaceutical/Athena Neurosciences Inc, South San Francisco, CA.
  3. 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 -]):
  4. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide