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Siltuximab Pregnancy and Breastfeeding Warnings

Siltuximab is also known as: Sylvant

Medically reviewed on August 28, 2017

Siltuximab Pregnancy Warnings

Animal studies have not revealed evidence of embryofetotoxicity, but siltuximab 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.

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 not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Comments: 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: Unknown

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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