Brodalumab Pregnancy and Breastfeeding Warnings

Brand names: Siliq

Medically reviewed by Drugs.com. Last updated on Mar 5, 2024.

Brodalumab Pregnancy Warnings

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.

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.

See references

Brodalumab Breastfeeding Warnings

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.

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.

See references

Further information

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