Dacomitinib Pregnancy and Breastfeeding Warnings

Brand names: Vizimpro

Medically reviewed by Drugs.com. Last updated on Jun 1, 2023.

Dacomitinib Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity 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.

Use is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration during the period of organogenesis resulted in an increased incidence of post-implantation loss and reduced fetal body weight at doses equivalent to the recommended human dose. The absence of EGFR signaling has been shown to result in embryolethality as well as postnatal death in animals.

Comments:
-Advise females of reproductive potential to use effective contraception during therapy and for at least 17 days after the final dose.
-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.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.

See references

Dacomitinib Breastfeeding Warnings

Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-This drug can harm a nursing infant.
-Women should not breastfeed during therapy and for at least 17 days after.

No information is available on the use of this drug during breastfeeding. Because it is 98% bound to plasma proteins, the amount in milk is likely to be low; however, because of its potential toxicity in the breastfed infant and its half-life of 70 hours, the manufacturer recommends that breastfeeding be discontinued during therapy and for at least 17 days after.

See references

Further information

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