Avatrombopag Pregnancy and Breastfeeding Warnings

Brand names: Doptelet

Medically reviewed by Drugs.com. Last updated on Jun 22, 2023.

Avatrombopag Pregnancy Warnings

This drug is not recommended during pregnancy and in women of childbearing potential not using contraception.
According to some authorities: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

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

Risk Summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Based on animal studies, this drug may cause fetal harm.
-Advise pregnant women of the potential risk to a fetus.
-Advise females of childbearing potential to use contraception if treated with this drug.
-Advise females to inform their prescriber of a known or suspected pregnancy.

Animal studies have revealed increased pup mortality at a dose that resulted in maternal exposures 43-times and pup exposures approximately 3-times the AUC observed in patients at the maximum recommended dose of 60 mg once a day. There are no controlled data in human pregnancy.

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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Avatrombopag Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for at least 2 weeks after the last dose.

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

Comments:
-The effects in the nursing infant are unknown.
-If a lactating woman requires short-term administration of this drug, such as before an invasive procedure, it is recommended to temporarily discontinue breastfeeding. During the treatment period and for two weeks following the last dose of this drug, breast milk should be expressed and discarded to minimize the potential exposure of a breastfeeding infant to the medication.

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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