Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Pregnancy
There are no adequate data for the use of erlotinib in pregnant women. Studies in animals have shown no evidence of teratogenicity or abnormal parturition. However, an adverse effect on the pregnancy can not be excluded as rat and rabbit studies have shown increased embryo/foetal lethality (see section 5.3). The potential risk for humans is unknown.
Women of childbearing potential
Women of childbearing potential must be advised to avoid pregnancy while on ERLOTINIB S.K. Adequate contraceptive methods should be used during therapy, and for at least 2 weeks after completing therapy. Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the foetus.
Breast-feeding
It is not known whether erlotinib is excreted in human milk. No studies have been conducted to assess the impact of ERLOTINIB S.K on milk production or its presence in breast milk. As the potential for harm to the nursing infant is unknown, mothers should be advised against breast-feeding while receiving ERLOTINIB S.K and for at least 2 weeks after the final dose.
Fertility
Studies in animals have shown no evidence of impaired fertility. However, an adverse effect on the fertility can not be excluded as animal studies have shown effects on reproductive parameters (see section 5.3). The potential risk for humans is unknown.