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Icatibant Pregnancy and Breastfeeding Warnings

Icatibant is also known as: Firazyr

Medically reviewed by Drugs.com. Last updated on Jun 4, 2020.

Icatibant Pregnancy Warnings

Animal studies have revealed premature birth, abortion, and delayed parturition. 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 to the fetus.

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

Risk Summary: A drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes has not been identified.

See references

Icatibant Breastfeeding Warnings

Benefit should outweigh risk; breastfeeding should not take place for 12 hours after treatment with this drug.

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

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Firazyr (icatibant)." Shire US Inc, Florence, KY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

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. Firazyr (icatibant)." Shire US Inc, Florence, KY.

Further information

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