Tucatinib Pregnancy and Breastfeeding Warnings

Brand names: Tukysa

Tucatinib Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on findings in animals and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-This drug is used in combination with trastuzumab and capecitabine. Refer to the full prescribing information of trastuzumab and capecitabine for pregnancy information.
-This drug can harm a developing fetus.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Advise females of reproductive potential to use effective contraception during therapy and for at least 1 week after.
-Advise male patients with female partners of reproductive potential to use effective contraception during therapy and for at least 1 week after.
Based on findings from animal studies, this drug may impair male and female fertility.

Animal studies during organogenesis resulted in embryofetal mortality, reduced fetal weight, and fetal abnormalities at maternal exposures greater than or equal to 1.3 times the human exposure (AUC) at the recommended dose. 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.

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Tucatinib Breastfeeding Warnings

Use is not recommended.

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

Comments:
-This drug is used in combination with trastuzumab and capecitabine. Refer to the full prescribing information of trastuzumab and capecitabine for lactation information.
-There are no data on the presence of this drug or its metabolites in human or animal milk or its effects on the breastfed child or on milk production.
-Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during therapy and for at least 1 week after.

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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