Ixekizumab Pregnancy and Breastfeeding Warnings

Brand names: Taltz

Ixekizumab Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.
-According to some authorities: Use should be avoided.

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

Risk Summary:
-No data available on use of this drug in pregnant women to inform a drug-related risk.
-Human IgG is known to cross the placental barrier; therefore, this drug may be transmitted from mother to developing fetus.

Comments:
-Based on its mechanism of action, this drug may affect neonatal immunity during pregnancy.
-Women of childbearing potential should use an effective method of contraception during and for at least 10 weeks after therapy.
-A pregnancy exposure registry is available.

In animal studies, doses up to 19 times the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus. When dosing was continued until parturition, neonatal deaths were observed at 1.9 times the MRHD. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established.

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

Ixekizumab Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, considering the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant or on milk production are unknown.
-When a drug is present in animal milk, it is likely that the drug will be present in human milk.
-Until more data is available, this drug should be used with caution during breastfeeding, especially when breastfeeding a newborn or preterm infant.

In animal studies, this drug was detected in the milk of lactating cynomolgus monkeys.

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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