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 this medicinal product: at least 2 months for females and 4 months for males. A risk for decreased exposure of hormonal contraceptives cannot be excluded.
Pregnancy: There are no or limited amount of data from the use of osimertinib in pregnant women. Studies in animals have shown reproductive toxicity (embryolethality, reduced foetal growth, and neonatal death (see Pharmacology: Toxicology: Preclinical safety data under Actions). Based on its mechanism of action and preclinical data, osimertinib may cause foetal harm when administered to a pregnant woman. TAGRISSO should not be used during pregnancy unless the clinical condition of the woman requires treatment with osimertinib.
Breast-feeding: It is not known whether osimertinib or its metabolites are excreted in human milk. There is insufficient information on the excretion of osimertinib or its metabolites in animal milk. However, osimertinib and its metabolites were detected in the suckling pups and there were adverse effects on pup growth and survival (see Pharmacology: Toxicology: Preclinical safety data under Actions). 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 osimertinib has effects on male and female reproductive organs and could impair fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).