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Icatibant Pregnancy and Breastfeeding Warnings

Icatibant is also known as: Firazyr

Medically reviewed on September 19, 2017

Icatibant Pregnancy Warnings

Animal studies have revealed preimplantation loss, abortion, fetal death, premature birth, 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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: C

See references

Icatibant Breastfeeding Warnings

AU and UK: Breastfeeding should not take place for 12 hours after treatment with this drug.
US: Caution is recommended.

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.

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