Herceptin/Herceptin SC Use In Pregnancy & Lactation

Females and Males of Reproductive Potential: Fertility: It is not known whether Herceptin can affect reproductive capacity. Animal reproduction studies revealed no evidence of impaired fertility or harm to the foetus (see Pharmacology: Toxicology: Nonclinical Safety: Reproductive Toxicity under Actions).
Contraception: Women of childbearing potential should be advised to use effective contraception during treatment with Herceptin IV or Herceptin SC formulation and for 7 months after treatment has concluded (see Pharmacology: Pharmacokinetics under Actions).
Pregnancy: Herceptin 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 of which resulted in fatal pulmonary hypoplasia of the foetus, have been reported in pregnant women receiving Herceptin. Women who become pregnant should be advised of the possibility of harm to the foetus. If a pregnant woman is treated with Herceptin, or if a patient becomes pregnant while receiving Herceptin or within 7 months following last dose of Herceptin, close monitoring by a multidisciplinary team is desirable.
Labour and Delivery: No data to report.
Lactation: It is not known whether trastuzumab is secreted in human milk. As human immunoglobulin G (IgG) is secreted into human milk, and the potential for harm to the infant is unknown, breast-feeding should be avoided during Herceptin therapy (see Pharmacology: Toxicology: Nonclinical Safety: Other under Actions).