IncobotulinumtoxinA Pregnancy and Breastfeeding Warnings

Brand names: Xeomin

Medically reviewed by Drugs.com. Last updated on Feb 1, 2024.

IncobotulinumtoxinA Pregnancy Warnings

Benefit should outweigh risk

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk Summary: Data on the developmental risk associated with use in pregnant women is not available; this drug has been shown to be embryotoxic in rats and has caused increased abortions in rabbits when given at doses estimated to be higher than the maximum recommended human dose.

Intramuscular administration of various doses to pregnant rats during organogenesis showed decreased fetal body weight and skeletal ossification at doses that were also maternally toxic. In rabbits, an increased rate of abortion was seen at maternally toxic doses. The significance of the findings are considered uncertain in humans and are consistent with those reported for other botulinum neurotoxin type A agents. 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 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.

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IncobotulinumtoxinA Breastfeeding Warnings

Benefit should outweigh risk

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

Comments:
-The effects in the nursing infant are unknown.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal conditions.

Using currently available analytical technology, it is not possible to detect this drug in the systemic circulation following intramuscular or intraglandular injection at the recommended dose, thus excretion into breast milk is considered unlikely.

See references

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