DaxibotulinumtoxinA Pregnancy and Breastfeeding Warnings

Brand names: Daxxify

Medically reviewed by Drugs.com. Last updated on Sep 19, 2023.

DaxibotulinumtoxinA Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary:
No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Intramuscular administration of this drug at doses associated with paternal or maternal toxicity decreased fertility, weight gain, and food intake.

Animal studies have revealed evidence of decreased fetal body weight and skeletal ossification at maternally toxic doses around 40 times the maximum recommended human dose (MRHD). No embryofetal developmental toxicity was observed at doses up to 10 units/kg in rats, which is 15 times the MRHD and up to 0.48 units/kg/day in rabbits, which is equivalent to the MRHD. There are no controlled data in human pregnancy.

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

DaxibotulinumtoxinA Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
-The effects in the nursing infant or on milk production are unknown.
-This drug should be used during breastfeeding only if the benefit outweighs the risk to the infant.
-Botulinum toxin was not detectable systemically after intramuscular administration; therefore excretion in milk is unlikely.

See references

Further information

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

Medical Disclaimer