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Rituximab Pregnancy and Breastfeeding Warnings

Rituximab is also known as: Rituxan

Medically reviewed on Sep 4, 2018

Rituximab Pregnancy Warnings

Offspring of pregnant animals exposed to this drug did not exhibit any teratogenic effects but did have decreased lymphoid tissue B cells regardless of the timing of exposure. The B cell counts returned to normal levels, and immunologic function was restored within 6 months postpartum. 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 the benefit outweighs the risk.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Comments:
-Women of childbearing potential should use effective contraception while taking this drug and for 12 months following treatment.
-Postmarketing data indicate that B cell lymphocytopenia generally lasting less than 6 months can occur in infants exposed to this drug in utero. This drug was detected postnatally in the serum of infants exposed in utero.

See references

Rituximab Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Unknown; however, IgG is excreted into human milk
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Because maternal IgG is excreted in human milk, and this drug is detectable in milk from animal studies, women should not breastfeed while treated with this drug and for 12 months following the last dose.

-Published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts.
-No information is available on the clinical use of this drug during breastfeeding.
-Because this drug is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.
-Some experts say that if this drug is required by the mother, it is not a reason to discontinue breastfeeding.

See references

References for pregnancy information

  1. "Product Information. Rituxan (rituximab)." Genentech, South San Francisco, CA.
  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]):

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Rituxan (rituximab)." Genentech, South San Francisco, CA.
  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. 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 -]):

Further information

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

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