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Erlotinib Pregnancy and Breastfeeding Warnings

Erlotinib is also known as: Tarceva

Erlotinib Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

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

Risk Summary: Based on animal data and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Limited available data in pregnant women are not sufficient to inform a risk of major birth defects or miscarriage. When given during organogenesis, embryofetal lethality and abortion occurred in animals at exposures approximately 3 times the exposure at the recommended human daily dose.

-Women of childbearing potential should use adequate contraception during therapy and for at least 2 weeks following the last 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.

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.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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

Erlotinib Breastfeeding Warnings

No information is available on the use of this drug during breastfeeding. Because it is 93% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is about 36 hours and it might accumulate in the infant. It is also given in combination with gemcitabine for pancreatic cancer, which may increase the risk to the infant.

Use is not recommended.

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

-This drug has the potential to cause serious adverse reactions in breastfed infants, including interstitial lung disease, hepatotoxicity, bullous and exfoliative skin disorders, microangiopathic hemolytic anemia with thrombocytopenia, ocular disorders, and diarrhea.
-The manufacturer recommends that breastfeeding be discontinued during therapy and for 2 weeks after the final dose.

See references

References for pregnancy information

  1. "Product Information. Tarceva (erlotinib)." Genentech (2004):

References for breastfeeding information

  1. "Product Information. Tarceva (erlotinib)." Genentech (2004):

Further information

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