Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential/contraception
Women of childbearing potential should use effective contraception while receiving Phesgo and for 7 months following the last dose.


Pregnancy
In animal studies pertuzumab has shown reproductive toxicity. There is only a limited amount of data from the use of pertuzumab in pregnant women.

From animal studies, it is not known whether trastuzumab can affect reproductive capacity (see section 5.3). However, in the post-marketing setting, cases of foetal renal growth and/or function impairment in association with oligohydramnios, some of which resulted in fatal pulmonary hypoplasia of the foetus, have been reported in pregnant women receiving trastuzumab.

Based on the aforementioned animal studies and post-marketing data, Phesgo should therefore be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus. Women who become pregnant should be advised of the possibility of harm to the foetus. If a pregnant woman is treated with Phesgo, or if a patient becomes pregnant while receiving Phesgo or within 7 months following the last dose of Phesgo, close monitoring by a multidisciplinary team is desirable.

Breast-feeding

As human IgG is secreted into human milk and the potential for absorption and harm to the infant is unknown, women should not breast-feed during Phesgo therapy and for at least 7 months following the last dose.

Fertility

Pertuzumab
No specific fertility studies in animals have been performed to evaluate the effect of pertuzumab. No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies of pertuzumab for up to six-month duration in cynomolgus monkeys (see section 5.3).

Trastuzumab

Reproduction studies conducted in cynomolgus monkeys with trastuzumab revealed no evidence of impaired fertility in female cynomolgus monkeys (see section 5.3).