Taltz Pregnancy Warnings
Doses up to 19 times the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus in animal studies. When dosing was continued until parturition, neonatal deaths were observed at 1.9 times the MRHD. 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.
This drug should be used during pregnancy only if the benefit outweighs the risk.
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned
Risk Summary: Human IgG crosses the placental barrier; therefore, this drug may be transmitted from the mother to the 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 therapy and for at least 10 weeks after therapy.
See references
Taltz 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: Yes
Comment: The effects in the nursing infant are unknown.
Until more data become available, this drug should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. Because it is a large protein molecule with a molecular weight of 146,000, absorption by the infant is unlikely after the first few weeks postpartum, and it will probably be destroyed in the infant GI tract.
See references
