Animal studies revealed evidence of oligohydramnios, delayed fetal kidney development, and embryofetal deaths. Use of trastuzumab during pregnancy has resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting in the fetus as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. These case reports described oligohydramnios in pregnant women who received trastuzumab either alone or in combination with chemotherapy. In some case reports, amniotic fluid index increased after trastuzumab was stopped.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling Genentech at 1-888-835-2555.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Use should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary: This drug combination can cause fetal harm when administered to a pregnant woman. The use of IV trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In an animal reproduction study, administration of pertuzumab to pregnant cynomolgus monkeys during organogenesis resulted in oligohydramnios, delayed fetal kidney development, and embryofetal deaths at clinically relevant exposures that were 2.5 to 20-fold greater than exposures in humans receiving the recommended dose.

Comments:
-A pregnancy exposure registry is available.
-This drug can harm a developing fetus.
-Do not administer this drug combination during pregnancy or within 7 months prior to conception.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Monitor women who received this drug combination during pregnancy or within 7 months prior to conception for oligohydramnios.

See references

Benefit should outweigh risk.

Excreted into human milk: Data not available (hyaluronidase/pertuzumab/trastuzumab); Yes (human IgG)
Excreted into animal milk: Yes (trastuzumab); unknown (hyaluronidase/pertuzumab)

Comments:
-The effects in the nursing infant are unknown.
-The healthcare provider should take into account the elimination half-life of pertuzumab and the trastuzumab wash out period of 7 months.

See references