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Omalizumab Pregnancy and Breastfeeding Warnings

Omalizumab is also known as: Xolair

Medically reviewed by Last updated on Oct 18, 2018.

Omalizumab Pregnancy Warnings

Use is not recommended unless clearly needed.

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

Comments: A pregnancy registry is available.

Animal studies have failed to reveal evidence of fetal harm in doses up to 10 times the maximum recommended human dose. This drug may have its greatest effect during the third trimester; however, there are no controlled data in human pregnancy.

This drug crosses the placental barrier and the potential for harm to the fetus is unknown. This drug has been associated with age-dependent decreases in blood platelets in non-human primates, with a greater relative sensitivity in juvenile animals.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-866-496-5247 or visiting

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 reproductive studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Omalizumab Breastfeeding Warnings

Animal models have shown milk levels up to 0.15% of the maternal serum concentration following subcutaneous dosing during pregnancy. This drug is a monoclonal antibody (IgG1 kappa) and immunoglobulin G is present in human milk; however, there are no data regarding the presence of this drug in human milk.

Use is not recommended.

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

Comments: The effects on the nursing infant are unknown.

See references

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL:" ([1999]):
  2. "Product Information. Xolair (omalizumab)." Genentech, South San Francisco, CA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Xolair (omalizumab)." Genentech, South San Francisco, CA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

Further information

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