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Alemtuzumab Pregnancy and Breastfeeding Warnings

Alemtuzumab is also known as: Campath, Lemtrada

Medically reviewed on March 14, 2018

Alemtuzumab Pregnancy Warnings

In animal studies no teratogenic effects were observed. However, there was an increase in embryolethality (increased post-implantation loss and the number of dams with all fetuses dead or resorbed) in pregnant animals dosed during gestation days 11 through 15. There are no controlled data in human pregnancy.

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.

AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

AU: B-cell chronic lymphocytic leukemia (B-CLL): Use is contraindicated; Multiple Sclerosis (MS): This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.
UK, US: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B2 for B-CLL; B3 for MS
US FDA pregnancy category: C

Comments:
-AU: B-CLL: Males and females of childbearing potential should use effective contraceptive measures during therapy and for 6 months following the end of therapy.
-MS: Women of child bearing potential should use effective contraceptive measures during therapy and for 4 months following the end of therapy.
-Human IgG antibodies, such as this drug, cross the placental barrier and could potentially cause fetal B and T cell lymphocyte depletion.

See references

Alemtuzumab Breastfeeding Warnings

No information is available on the use of this drug during breastfeeding. Because it 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. Until more data are available, this drug should be used with caution or avoided during breastfeeding, especially while nursing a newborn or preterm infant.

AU: B-cell chronic lymphocytic leukemia (B-CLL): Use is contraindicated; Multiple Sclerosis (MS): Breast feeding should be discontinued during each course of treatment and for 4 months following the last infusion of each treatment course.
UK, US: 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: Unknown
Excreted into animal milk: Yes

See references

References for pregnancy information

  1. "Product Information. Campath (alemtuzumab)" Berlex, Richmond, 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. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  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. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Campath (alemtuzumab)" Berlex, Richmond, CA.

Further information

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

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