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Brodalumab Pregnancy and Breastfeeding Warnings

Brodalumab is also known as: Siliq

Medically reviewed on Mar 29, 2017

Brodalumab Pregnancy Warnings

In animal studies, no adverse developmental effects were observed in offspring after subcutaneous administration of this drug during organogenesis through parturition at doses up to 26 times the maximum recommended human dose (MRHD). There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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.

US FDA pregnancy category: Not assigned.

Risk Summary: There are no data on the use of this drug in pregnant women. Human IgG antibodies are known to cross the placental barrier; therefore, the drug may be transmitted from the mother to the developing fetus.

Comments:
-Women of childbearing potential should use an effective method of contraception during therapy and for at least 12 weeks after therapy has ended.

See references

Brodalumab Breastfeeding Warnings

No information is available on the clinical 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.

UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
US: Benefit should outweigh risk.

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

Comments:
-The effects in the breastfed infant are unknown.
-This drug is a monoclonal antibody and is expected to be present in the first milk and at low levels afterwards.

See references

References for pregnancy information

  1. "Product Information. Siliq (brodalumab)." Valeant Pharmaceuticals, Costa Mesa, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. 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 -]):
  2. "Product Information. Siliq (brodalumab)." Valeant Pharmaceuticals, Costa Mesa, 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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