Afinitor Use In Pregnancy & Lactation

Women of childbearing potential/Contraception in males and females: Women of childbearing potential must use a highly effective method of contraception (e.g. oral, injected, or implanted non-oestrogen-containing hormonal method of birth control, progesterone-based contraceptives, hysterectomy, tubal ligation, complete abstinence, barrier methods, intrauterine device [IUD], and/or female/male sterilisation) while receiving everolimus, and for up to 8 weeks after ending treatment. Male patients should not be prohibited from attempting to father children.
Pregnancy: There are no adequate data from the use of everolimus in pregnant women. Studies in animals have shown reproductive toxicity effects including embryotoxicity and foetotoxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown.
Everolimus is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breast-feeding: It is not known whether everolimus is excreted in human breast milk. However, in rats, everolimus and/or its metabolites readily pass into the milk (see Pharmacology: Toxicology: Preclinical safety data under Actions). Therefore, women taking everolimus should not breast-feed during treatment and for 2 weeks after the last dose.
Fertility: The potential for everolimus to cause infertility in male and female patients is unknown, however amenorrhoea (secondary amenorrhoea and other menstrual irregularities) and associated luteinising hormone (LH)/follicle stimulating hormone (FSH) imbalance has been observed in female patients (see also Pharmacology: Toxicology: Preclinical safety data under Actions for preclinical observations on the male and female reproductive systems). Based on non-clinical findings, male and female fertility may be compromised by treatment with everolimus (see Pharmacology: Toxicology: Preclinical safety data under Actions).