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Contraception in males and females: Women of childbearing potential should be advised to avoid becoming pregnant while receiving TAGRISSO. Patients should be advised to use effective contraception for the following periods after completion of treatment with TAGRISSO: at least 6 weeks for females and 4 months for males.
Pregnancy: There are no or limited amount of data from the use of TAGRISSO in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Based on its mechanism of action and preclinical data, TAGRISSO may cause foetal harm when administered to a pregnant woman. Administration of osimertinib to pregnant rats was associated with embryolethality, reduced foetal growth and neonatal death at exposures similar to what is expected in humans (see Pharmacology: Toxicology: Preclinical safety data under Actions). TAGRISSO is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is not known whether osimertinib or its metabolites are excreted in human milk. Administration to rats during gestation and early lactation was associated with adverse effects, including reduced growth rates and neonatal death. There is insufficient information on the excretion of osimertinib or its metabolites in animal milk. A risk to the suckling child cannot be excluded. Breast-feeding should be discontinued during treatment with TAGRISSO.
Fertility: There are no data on the effect of TAGRISSO on human fertility. Results from animal studies have shown that TAGRISSO has effects on male and female reproductive organs and could impair fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).
