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Afatinib Pregnancy and Breastfeeding Warnings

Afatinib is also known as: Gilotrif

Afatinib Pregnancy Warnings

Use should be avoided.

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

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

-This drug can harm a developing fetus.
-Advise females of reproductive potential to use contraception during therapy with this drug, and for at least 2 weeks after 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.
-Based on animal studies, this drug may reduce fertility in females and males of reproductive potential. It is not known if the effects on fertility are reversible.

Administration of this drug to pregnant animals during organogenesis at exposures approximately 0.2 times the exposure in humans at the recommended dose of 40 mg daily resulted in embryotoxicity and maternal toxicity and increased abortions at late gestational stages. There are no controlled data in human pregnancy.

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

Afatinib Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

-It is likely that this drug is excreted into human milk. A risk to the nursing child cannot be excluded.
-Breastfeeding should be discontinued during therapy with this drug and for 2 weeks after the last dose.

No information is available on the use of this drug during breastfeeding. Because it is about 95% bound to plasma proteins, the amount in milk is likely to be low; however, its half-life is about 37 hours and it might accumulate in the infant.

See references

References for pregnancy information

  1. Cerner Multum, Inc. Australian Product Information.
  2. Product Information. Gilotrif (afatinib). Boehringer Ingelheim. 2013.

References for breastfeeding information

  1. Product Information. Gilotrif (afatinib). Boehringer Ingelheim. 2013.

Further information

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