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Defibrotide Pregnancy and Breastfeeding Warnings

Defibrotide is also known as: Defitelio

Medically reviewed by Last updated on Jul 6, 2020.

Defibrotide Pregnancy Warnings

Animal studies have revealed a decreased number of implantations and viable fetuses. Assessment of embryofetal toxicity could not be completed in rats or rabbits due to high maternal mortality, abortion, and fetal resorption at all doses. 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.

UK: Use is not recommended unless clearly needed.
US: The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Risk Summary: No data exists regarding use of this drug in pregnant women. Advise pregnant women of the potential risk of miscarriage.

See references

Defibrotide Breastfeeding Warnings

US: Breastfeeding is not recommended during use of this drug.
UK: Use is considered acceptable.

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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Defitelio (defibrotide)." Jazz Pharmaceuticals, Palo Alto, CA.

References for breastfeeding information

  1. "Product Information. Defitelio (defibrotide)." Jazz Pharmaceuticals, Palo Alto, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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