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Alemtuzumab Pregnancy and Breastfeeding Warnings

Alemtuzumab is also known as: Campath, Lemtrada

Medically reviewed by Drugs.com. Last updated on Mar 15, 2019.

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). There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to Lemtrada (R), a pregnancy registry has been established. Physicians are encouraged to register patients by calling 1-866-758-2990 or online at pregnancyregistries@increasearch.com.

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.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: LEMTRADA (R): Not assigned; CAMPATH (R): C

Risk Summary: There are no adequate data on the developmental risk associated with the use of this drug in pregnant women. It was embryolethal in animal studies when administered during organogenesis. Autoantibodies may develop after administration. Placental transfer of antithyroid antibodies resulting in neonatal Graves' disease has been reported.

Comments:
-A pregnancy exposure registry is available.
-This drug induces persistent thyroid disorders. Untreated hypothyroidism in pregnant women increases the risk for miscarriage and may have effects on the fetus including mental retardation and dwarfism. In mothers with Graves' disease, maternal thyroid stimulating hormone receptor antibodies can be transferred to a developing fetus and can cause neonatal Graves' disease.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Women of childbearing potential should use effective contraceptive measures when receiving this drug and for 4 months after.

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 become available, this drug should be used with caution or avoided during breastfeeding, especially while nursing a newborn or preterm infant.

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

Comments:
-The effects in the nursing infant are unknown.
-IgG antibodies, such as this drug can be excreted in human milk.

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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  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. "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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