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Ingenol topical Pregnancy and Breastfeeding Warnings

Ingenol topical is also known as: Picato

Medically reviewed on August 28, 2017

Ingenol topical Pregnancy Warnings

Animal studies have shown slight embryo-fetal toxicity. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

Use should be avoided.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

See references

Ingenol topical Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-Physical contact between the newborn/infant and the treated area should be avoided for a period of 6 hours after application of this drug.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Picato (ingenol topical)." Leo Pharma Inc, Parsippany, NY.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Picato (ingenol topical)." Leo Pharma Inc, Parsippany, NY.

Further information

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

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