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Ixekizumab Pregnancy and Breastfeeding Warnings

Ixekizumab is also known as: Taltz

Ixekizumab 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

Ixekizumab Breastfeeding Warnings

AU, UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: This drug should be used during pregnancy only if the benefit outweighs the risk. 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

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Taltz Autoinjector (ixekizumab)." Eli Lilly and Company, Indianapolis, IN.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Taltz Autoinjector (ixekizumab)." Eli Lilly and Company, Indianapolis, IN.
  4. 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 -]):

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