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IncobotulinumtoxinA Pregnancy and Breastfeeding Warnings

IncobotulinumtoxinA is also known as: Xeomin

Medically reviewed on Sep 6, 2018

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.

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. The no-effect level for embryotoxicity was 6 Units/kg, a dose representing 3 times the maximum recommended human dose (MRHD) for cervical dystonia. In rabbits, an increased rate of abortion was seen at maternally toxic doses. The no-effect level for increased abortions was 2.5 Units/kg, a dose approximately that of the MRHD dose for cervical dystonia. 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.

See references

IncobotulinumtoxinA Breastfeeding Warnings

Use is not recommended.

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

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "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.

Further information

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

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