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Denileukin diftitox Pregnancy and Breastfeeding Warnings

Brand names: Ontak

Denileukin diftitox Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: Not Assigned

Animal reproduction studies have not been conducted. There have not been any studies to assess the effect on fertility. There are no controlled data in human pregnancy.

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

Denileukin diftitox 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: Data not available

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. (2001) "Product Information. Ontak (denileukin diftitox)." Ligand Pharmaceuticals

References for breastfeeding information

  1. (2001) "Product Information. Ontak (denileukin diftitox)." Ligand Pharmaceuticals

Further information

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