Spesolimab Pregnancy and Breastfeeding Warnings

Brand names: Spevigo

Medically reviewed by Drugs.com. Last updated on Nov 18, 2022.

Spesolimab Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary:
No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Human IgG is known to cross the placental barrier; therefore, this drug is likely to be transferred from the mother to the developing fetus.
-There are no data on the developmental risk associated with the use of this drug in pregnant women.

Animal studies have failed to reveal evidence of fetal harm. Biweekly intravenous administration of surrogate monoclonal antibody against IL36R at doses up to 50 mg/kg to female mice from gestation day 6 through lactation day 18 resulted in no adverse effects on postnatal development neurobehavioral, or reproductive performance of the offspring. There are no controlled data in human pregnancy.

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

Spesolimab Breastfeeding Warnings

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: Data not available
Excreted into animal milk: Unknown

Comments:
-Human IgG is excreted in human milk.
-The effects in the nursing infant are unknown.

See references

Further information

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