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Avatrombopag Pregnancy and Breastfeeding Warnings

Avatrombopag is also known as: Doptelet

Medically reviewed by Drugs.com. Last updated on Jul 2, 2019.

Avatrombopag Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on animal studies, this drug may cause fetal harm.

Comments:
-Advise pregnant women of the potential risk to a fetus.
-Advise females of reproductive potential 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 recommended dose of 60 mg once a day. 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

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.

See references

References for pregnancy information

  1. "Product Information. Doptelet (avatrombopag)." Dova Pharmaceuticals, Durham, NC.

References for breastfeeding information

  1. "Product Information. Doptelet (avatrombopag)." Dova Pharmaceuticals, Durham, 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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