Females and Males of Reproductive Potential: Fertility: No specific fertility studies in animals have been performed to evaluate the effects of Phesgo.
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 pertzumab for up to six month duration in cynomolgus monkeys (see Pharmacology: Toxicology: Nonclinical Safety: Impairment of Fertility under Actions).
Reproduction studies conducted in cynomolgus monkeys with trastuzumab revealed no evidence of impaired fertility in female cynomolgus monkeys (see Pharmacology: Toxicology: Nonclinical Safety: Impairment of Fertility under Actions).
Contraception: Women of childbearing potential including those who are partners of male patients should use effective contraception during treatment with Phesgo and for 7 months following the last dose of Phesgo.
Pregnancy: Phesgo should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus.
No clinical studies of Phesgo in pregnant women have been performed. Pertuzumab administered intravenously to cynomolgus monkeys during organogenesis led to oligohydramnios, delayed renal development and embryo fetal death (see Pharmacology: Toxicology: Nonclinical Safety: Reproductive toxicity under Actions). In the post-marketing setting for trastuzumab, cases of fetal renal growth and/or function impairment in association with oligohydramnios, some of which resulted in fatal pulmonary hypoplasia of the fetus, have been reported in pregnant women.
Based on the aforementioned animal studies and post-marketing data, Phesgo has the potential to cause fetal harm when administered to a pregnant woman. Women who become pregnant should be advised of the possibility of harm to the fetus. 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.
Labor and Delivery: The safe use of Phesgo during labor and delivery has not been established.
Lactation: As human IgG is excreted in human milk, and the potential for absorption and harm to the infant is unknown, women should be advised to discontinue nursing during Phesgo therapy and for 7 months after the last dose of Phesgo.