Pregnancy: Perjeta should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus.
There are no studies of Perjeta in pregnant women. Perjeta administered to cynomolgus monkeys during organogenesis led to oligohydramnios, delayed renal development and embryo fetal death (see Pharmacology: Toxicology: Non-Clinical Safety: Teratogenicity under Actions). Therefore, based on these animal studies and the mechanism of action Perjeta is considered to have the potential to cause fetal harm when administered to a pregnant woman.
Labor and delivery: The safe use of Perjeta during labor and delivery has not been established.
Lactation: Because human IgG is secreted in human milk and the potential for absorption and harm to the infant is unknown, a decision should be made to discontinue nursing or the Perjeta-treatment, taking into account the importance to the mother and the elimination half-life of pertuzumab (see Pharmacology: Pharmacokinetics: Elimination under Actions).