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Osimertinib Pregnancy and Breastfeeding Warnings

Osimertinib is also known as: Tagrisso

Medically reviewed on April 10, 2017

Osimertinib Pregnancy Warnings

Safety has not been established during pregnancy; this drug may cause fetal harm and fertility impairment based on its mechanism of action and animal studies.

US FDA pregnancy category: Not Assigned

Comments:
-Females of reproductive potential should be advised to use effective contraception during treatment and for 6 weeks after the final dose.
-Males with female partners of reproductive potential should be advised to use effective contraception during treatment and for 4 months after the final dose.

Animal studies have revealed embryolethality and reduced fetal growth at plasma exposures 1.5 times the exposure at the recommended human dose. Data from animal studies also showed fertility impairment in males and females. It is not known if the fertility effects are reversible, but there was evidence of reversibility in some animals. 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

Osimertinib Breastfeeding Warnings

Breastfeeding is not recommended during treatment and for 2 months after the final dose.

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

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

See references

References for pregnancy information

  1. "Product Information. Tagrisso (osimertinib)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

References for breastfeeding information

  1. "Product Information. Tagrisso (osimertinib)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

Further information

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

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