Avacopan Pregnancy and Breastfeeding Warnings

Brand names: Tavneos

Medically reviewed by Drugs.com. Last updated on Aug 2, 2022.

Avacopan Pregnancy Warnings

Safety has not been established during pregnancy.
- According to some authorities: This drug is not recommended during pregnancy and in women of childbearing potential not using contraception.

AU TGA pregnancy category: D
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:
-There are no data on the effects of this drug on human fertility.

Animal studies have revealed evidence of skeletal variation when orally administered to hamsters during organogenesis at exposure 5 times the maximum recommended human dose (MRHD). In rabbits, increased incidences of abortion and maternal toxicity were also reported at doses 0.6 times MRHD. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused, or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Avacopan Breastfeeding Warnings

This drug has not been measured in the milk of lactating animals; however, it was detected in the plasma of nursing offspring in a developmental study with hamsters at a pup-to-maternal plasma ratio of 0.37. This finding suggests that this drug is secreted into the milk of lactating hamsters.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the infant.

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

Comments:
-There are no data on the effects of this drug on the breastfed infant or its impact on milk production.

See references

Further information

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

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