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IncobotulinumtoxinA Pregnancy and Breastfeeding Warnings

IncobotulinumtoxinA is also known as: Xeomin

Medically reviewed on February 12, 2018

IncobotulinumtoxinA Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.

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

This drug showed minor adverse effects on embryo-fetal development and increased abortions in animal studies when given at doses higher than the maximum recommended human dose (MRHD). 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.

See references

IncobotulinumtoxinA Breastfeeding Warnings

AU: Use is not recommended.
US: Caution is recommended.

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

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Xeomin (botulinum toxin type A (obsolete) (botulinum toxin type A))." Merz Pharmaceuticals, Greensboro, NC.

References for breastfeeding information

  1. "Product Information. Xeomin (botulinum toxin type A (obsolete) (botulinum toxin type A))." Merz Pharmaceuticals, Greensboro, NC.
  2. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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