Women of childbearing potential/Contraception in males and females: Women of childbearing age being treated with Alunbrig should be advised not to become pregnant and men being treated with Alunbrig should be advised not to father a child during treatment. Women of reproductive potential should be advised to use effective non-hormonal contraception during treatment with Alunbrig and for at least 4 months following the final dose. Men with female partners of reproductive potential should be advised to use effective contraception during treatment and for at least 3 months after the last dose of Alunbrig.
Pregnancy: Alunbrig may cause foetal harm when administered to a pregnant woman. Studies in animals have shown reproductive toxicity (see Pharmacology: Pharmacokinetics under Actions). There are no clinical data on the use of Alunbrig in pregnant women. Alunbrig should not be used during pregnancy unless the clinical condition of the mother requires treatment. If Alunbrig is used during pregnancy, or if the patient becomes pregnant while taking this medicinal product, the patient should be apprised of the potential hazard to a foetus.
Breast-feeding: It is unknown whether Alunbrig is excreted in human milk. Available data cannot exclude potential excretion in human milk. Breast-feeding should be stopped during treatment with Alunbrig.
Fertility: No human data on the effect of Alunbrig on fertility are available. Based on repeat-dose toxicity studies in male animals, Alunbrig may cause reduced fertility in males (see Pharmacology: Pharmacokinetics under Actions). The clinical relevance of these findings to human fertility is unknown.