Secukinumab Pregnancy and Breastfeeding Warnings

Brand names: Cosentyx

Secukinumab Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: As a precaution, use should preferably be avoided.

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

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

Comments (according to some authorities):
-Patients of childbearing potential should use effective contraception during therapy and for at least 20 weeks after the last dose.
-Use of this drug during pregnancy may compromise fetal and neonatal immunity.
-If this drug was used during pregnancy, live vaccines should generally not be administered to neonates/infants for 16 weeks after the last maternal dose.

Animal studies have failed to reveal evidence of teratogenicity or embryofetal toxicity. Pregnant cynomolgus monkeys received weekly subcutaneous injections (at doses up to 30 times the maximum recommended human dose [on a mg/kg basis at a maternal dose of 150 mg/kg]) during organogenesis; no malformations or embryofetal toxicity were observed in their fetuses. This drug crossed the placenta in monkeys. 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 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

Secukinumab Breastfeeding Warnings

Until more data are available, caution is recommended, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.
-According to some experts: Use is considered acceptable.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.
-According to some authorities: If it is decided to discontinue breastfeeding, nursing should be stopped during therapy and up to 20 weeks after the last dose.
-Immunoglobulins are excreted into human milk; it is not known if this drug is absorbed systemically after intake.

Since this drug is a large protein molecule (molecular weight of 151 kilodaltons), the amount in milk is likely to be very low. This drug is also likely to be partially destroyed in the infant's gastrointestinal tract; absorption by the infant is probably minimal.

See references

Further information

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

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