Spesolimab Pregnancy and Breastfeeding Warnings

Brand names: Spevigo

Spesolimab Pregnancy Warnings

Use should be avoided during pregnancy unless the benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comment:
-Human immunoglobulin G (IgG) is known to cross the placental barrier; therefore, this drug may be transmitted from the mother to the developing fetus.

Animal studies have failed to reveal evidence of reproductive toxicity. Animal studies using a surrogate mouse-specific anti-interleukin-36 receptor monoclonal antibody did not show embryo-fetal lethality or fetal malformations, and did not show treatment-related effects on postnatal developmental, neurobehavioral, or reproductive performance/fertility of offspring. There are no controlled data in human pregnancy.

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 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.

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Spesolimab Breastfeeding Warnings

Until more data become available, caution is recommended, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: This drug may be used during breastfeeding after the first few days postpartum if clinically needed, and if therapy was discontinued before the last trimester of pregnancy, breastfeeding can be started immediately after birth.
-According to other authorities: 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: Data not available

Comments:
-According to some experts, waiting for up to 2 weeks postpartum to resume therapy may minimize transfer to the infant.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

Because this drug is a large protein molecule, the amount in milk is expected to be very low, and absorption is likely minimal due to partial degradation in the infant's gastrointestinal tract.

Maternal immunoglobulin G (IgG) is known to be present in human milk. Excretion of IgG antibodies in milk occurs during the first few days after birth and then decreases to low concentrations; thus, transfer of IgG antibodies to newborns through milk may occur during the first few days after birth.

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Further information

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

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