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Neratinib Pregnancy and Breastfeeding Warnings

Neratinib is also known as: Nerlynx

Medically reviewed on Sep 25, 2018

Neratinib Pregnancy Warnings

Administration of this drug in animals during organogenesis caused maternal toxicity, abortions, embryofetal death (increased resorptions), effects on long-term memory in male offspring, and fetal abnormalities (e.g., domed head, dilation of the brain ventricles, ventricular septal defect, misshapen and enlarged anterior fontanelles, enlarged posterior fontanelles) at maternal AUCs approximately 0.2 to 0.5 times the AUC in patients at the recommended human dose (RHD). Findings in animals also revealed tubular hypoplasia of the testes at approximately 0.4 times the RHD AUC; however doses approximately 0.5 times the RHD AUC caused no effects on mating or the ability to become pregnant. 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.

Safety has not been established during pregnancy.

US FDA pregnancy category: Not Assigned

Comments:
-Based on animal studies and its mechanism of action, this drug can cause fetal harm.
-Females of Reproductive Potential: Advise them of the potential fetal risk; perform a pregnancy test prior to treatment initiation; and instruct them to use effective contraception during treatment and for at least 1 month after the last dose.
-Males with Female Partners of Reproductive Potential: Advise them to use effective contraception during treatment and for 3 months after the last dose.

See references

Neratinib Breastfeeding Warnings

Breastfeeding is not recommended during treatment and for at least 1 month after the last dose.

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

Comments: The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Nerlynx (neratinib)." Puma Biotechnology, Inc., Los Angeles, CA.

References for breastfeeding information

  1. "Product Information. Nerlynx (neratinib)." Puma Biotechnology, Inc., Los Angeles, CA.

Further information

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

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