Skip to Content

Osimertinib Pregnancy and Breastfeeding Warnings

Osimertinib is also known as: Tagrisso

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.

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.