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Secukinumab Pregnancy and Breastfeeding Warnings

Secukinumab is also known as: Cosentyx

Medically reviewed on February 26, 2018

Secukinumab Pregnancy Warnings

This drug crossed the placenta in animal studies but failed to reveal evidence of fetotoxicity or teratogenicity when administered throughout organogenesis and late gestation up to 150 mg/kg/week; however, it may compromise the immunity of the fetus and neonate. There are no controlled data in human pregnancy.

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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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

Comments:
-If this drug has been used during pregnancy, administration of live vaccines to newborns/infants for 16 weeks after the mother's last dose is generally not recommended.
-Women of childbearing potential should use an effective method of contraception during therapy and for at least 20 weeks after therapy is terminated.

See references

Secukinumab Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown

Comments:
-The effects in the nursing infant are unknown.
-Some experts advise that breastfeeding should be discontinued during therapy and for up to 20 weeks after therapy is terminated.

No information is available on the clinical use of this drug during breastfeeding. Because it is a large protein molecule with a molecular weight of 151,000, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract. Until more data become available, it should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

See references

References for pregnancy information

  1. "Product Information. Cosentyx (secukinumab)." Novartis Pharmaceuticals, East Hanover, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Cosentyx (secukinumab)." Novartis Pharmaceuticals, East Hanover, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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