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Gefitinib Pregnancy and Breastfeeding Warnings

Brand names: Iressa

Medically reviewed by Last updated on Dec 11, 2023.

Gefitinib Pregnancy Warnings

Use should be avoided.

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

-This drug can harm a developing fetus.
-Verify negative pregnancy status in females of reproductive potential prior to initiating 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.
-Advise females of reproductive potential to use effective contraception during therapy and for at least 2 weeks after.
-This drug can cause reduced fertility in females of reproductive potential.

Animal studies have revealed evidence of reproductive toxicity, fetotoxicity, and neonatal death at doses below the recommended human dose (RHD), and reduced fertility in females at doses approximately equal to the RHD. 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

Gefitinib Breastfeeding Warnings

Animal studies indicate that this drug and its metabolites are present in the milk of lactating rats at a concentration of 11- to 19-fold higher than in maternal plasma after an oral dose of 5 mg/kg (30 mg/m2, about 0.2 times the recommended human dose on a mg/m2 basis).

Use is not recommended; according to some experts, use is contraindicated.

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

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Product Information. Iressa (gefitinib). Astra-Zeneca Pharmaceuticals. 2003.

References for breastfeeding information

  1. Product Information. Iressa (gefitinib). Astra-Zeneca Pharmaceuticals. 2003.

Further information

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