Herzuma Use In Pregnancy & Lactation

Pregnancy: Trastuzumab should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus. In the post-marketing setting, cases of foetal renal growth and/or function impairment in association with oligohydramnios, some associated with fatal pulmonary hypoplasia of the fetus, have been reported in pregnant women receiving trastuzumab. Women of child-bearing potential should be advised to use effective contraception during treatment with trastuzumab and for 7 months after treatment has been concluded (see Pharmacology: Pharmacokinetics under Actions). Women who become pregnant should be advised of the possibility of harm to the foetus. If a pregnant woman is treated with trastuzumab, or if a patient becomes pregnant while receiving trastuzumab or within 7 months following last dose of trastuzumab, close monitoring by a multidisciplinary team is desirable. It is not known whether trastuzumab can affect reproductive capacity. Animal reproduction studies revealed no evidence of impaired fertility or harm to the foetus (see Pharmacology: Toxicology: Preclinical Safety: Teratogenicity under Actions).
Nursing Mothers: It is not known whether trastuzumab is secreted in human milk. As human IgG is secreted into human milk, and the potential for harm to the infant is unknown, breast-feeding should be avoided during trastuzumab therapy (see Pharmacology: Toxicology: Preclinical Safety: Other under Actions).