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Siltuximab Pregnancy and Breastfeeding Warnings

Siltuximab is also known as: Sylvant

Medically reviewed on Aug 28, 2018

Siltuximab Pregnancy Warnings

Animal studies have not revealed evidence of embryofetotoxicity, but this drug crossed the placenta and fetal serum concentrations were similar to maternal concentrations. Decreases in globulin levels in pregnant animals and in the offspring were found. There are no adequate or well-controlled studies in pregnant women.

Infants born to pregnant women treated with siltuximab may be at increased risk of infection, and caution is advised in the administration of live vaccines to these infants.

Animal studies have revealed evidence of embryotoxicity and teratogenicity. 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.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Comments:
-As with other immunoglobulin G antibodies, this drug crosses the placenta as observed in animal studies; therefore, infants born to women treated with this drug may be at increased risk of infection, and caution is advised in the administration of live vaccines to these infants.
-Women of childbearing potential should be encouraged to use adequate methods of contraception during and for at least 3 months after therapy.

See references

Siltuximab 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: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

Animal studies showed decreased globulin levels in the offspring from days 30 to 120 of lactation.

See references

References for pregnancy information

  1. "Product Information. Sylvant (siltuximab)." Janssen Biotech, Inc., Horsham, PA, PA.

References for breastfeeding information

  1. "Product Information. Sylvant (siltuximab)." Janssen Biotech, Inc., Horsham, PA, PA.

Further information

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

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