Use is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action and animal studies, this drug can harm a developing fetus when administered to a pregnant woman. There are no data on its use in pregnant women; however, use of another HER2/neu receptor antagonist (trastuzumab) during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. There are clinical considerations if this drug is used in combination with trastuzumab during pregnancy or within 7 months prior to conception.

Comments:
-A pregnancy exposure registry is available.
-Pregnancy should be ruled out before beginning therapy.
-This drug can cause fetal harm when administered to a pregnant woman.
-If this drug is used during pregnancy or if the patient becomes pregnant during treatment, the patient should be advised of the potential hazard to the developing fetus.
-Females of reproductive potential should be advised to use effective contraception while receiving this drug and for 7 months following the last dose.
-Monitor women who receive this drug in combination with trastuzumab during pregnancy or within 7 months prior to conception for oligohydramnios. If oligohydramnios occurs, perform fetal testing appropriate for gestational age and consistent with standard of care.

Animal studies revealed evidence of oligohydramnios, delayed fetal kidney development, and embryofetal deaths. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Encourage women who receive this drug in combination with trastuzumab during pregnancy or within 7 months prior to conception, to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 or visiting http://www.motherpregnancyregistry.com/.

There is a pregnancy pharmacovigilance program for this drug. If this drug is administered during pregnancy, or if a patient becomes pregnant while receiving this drug or within 7 months following the last dose in combination with trastuzumab, health care providers and patients should immediately report the exposure to Genentech at 1-888-835-2555.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

See references

No information is available on the clinical use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.

A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Human IgG is excreted in human milk.
-The effects in the nursing infant are unknown.
-The manufacturer recommends that breastfeeding be discontinued during therapy and for 7 months after the last dose.

See references