Pregnancy: There are no adequate data from the use of Vectibix in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Pre-clinical safety data under Actions). The potential risk for humans is unknown. EGFR has been implicated in the control of prenatal development and may be essential for normal organogenesis, proliferation, and differentiation in the developing embryo. Therefore, Vectibix has the potential to cause foetal harm when administered to pregnant women.
Human IgG is known to cross the placental barrier, and panitumumab may therefore be transmitted from the mother to the developing foetus. In women of childbearing potential, appropriate contraceptive measures must be used during treatment with Vectibix, and for 2 months following the last dose. If Vectibix is used during pregnancy or if the patient becomes pregnant while receiving this medicinal product, she should be advised of the potential risk for loss of the pregnancy or potential hazard to the foetus.
Breast-feeding: It is unknown whether panitumumab is excreted in human breast milk. Because human IgG is secreted into human milk, panitumumab might also be secreted. The potential for absorption and harm to the infant after ingestion is unknown. It is recommended that women do not breast-feed during treatment with Vectibix and for 2 months after the last dose.
Fertility: Animal studies have shown reversible effects on the menstrual cycle and reduced female fertility in monkeys (see Pharmacology: Toxicology: Pre-clinical safety data under Actions). Panitumumab may impact the ability of a woman to become pregnant.