Gefitinib Pregnancy and Breastfeeding Warnings

Gefitinib is also known as: Iressa

Gefitinib Pregnancy Warnings

This drug should not be used during pregnancy unless clearly needed as it can cause fetal harm based on its mechanism of action and animal data. AU TGA pregnancy category: C US FDA pregnancy category: Not assigned Comments: Females of reproductive potential should be advised not to get pregnant during therapy; to use effective contraception during treatment and for at least 2 weeks following therapy completion; and of the potential hazard to a fetus/potential risk for pregnancy loss.

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.

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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).

-Discontinue breastfeeding during use of this drug. (AU, US) -Use of this drug is contraindicated during breastfeeding. (UK) Excreted into human milk: Unknown Excreted into animal milk: Yes

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