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Osimertinib Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Jun 9, 2021.

Osimertinib is also known as: Tagrisso

Osimertinib Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: Based on data from animal studies and its mechanism of action this drug can cause fetal harm when administered to a pregnant woman.

-Pregnancy should be ruled out prior to beginning therapy.
-Based on its mechanism of action and animal studies this drug can harm a developing fetus.
-Females of childbearing potential should be encouraged to use adequate methods of contraception during and for at least 6 weeks after therapy.
-Males treated with this drug should not father a child during and for at least 4 months after 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.

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.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

No information is available on the use of this drug during breastfeeding. Because it is 95% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is about 48 hours and it might accumulate in the infant.

Use is not recommended.

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

-The effects in the nursing infant and on milk production are unknown.
- Breastfeeding is not recommended during therapy and for 2 months after the final dose.

-The effects in the nursing infant are unknown.
-This drug can harm a nursing infant.

See references

References for pregnancy information

  1. "Product Information. Tagrisso (osimertinib)." Astra-Zeneca Pharmaceuticals (2015):

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network." (2013):
  2. "Product Information. Tagrisso (osimertinib)." Astra-Zeneca Pharmaceuticals (2015):

Further information

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