Use should be avoided.

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

Risk Summary: This drug can cause fetal harm when administered to a pregnant woman. Oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death were observed postmarketing in patients treated with trastuzumab, the antibody component of this drug. Based on its mechanism of action, the DM1 component of this drug can also cause embryofetal harm.

Comments:
-A pregnancy registry is available.
-Trastuzumab (a component of this drug) can cause fetal harm or death when administered to a pregnant woman.
-Women of childbearing potential should use effective contraception while receiving therapy and for 7 months following the last dose.
-Male patients with female partners of reproductive potential should use effective contraception during therapy and for 4 months following the last dose because of the potential for genotoxicity.
-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.

Animal studies suggest that DM1, the microtubule inhibiting cytotoxic component of this drug, is teratogenic and potentially embryotoxic. 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 during pregnancy or within 7 months prior to conception, to enroll in the MotHER Pregnancy Registry by visiting http://www.motherpregnancyregistry.com/.

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 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; however, its cytotoxic component (DM1) may cause serious reactions in breastfed infants.

Use should be avoided.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Based on its mechanism of action, the cytotoxic component (DM1) of this drug may cause serious adverse reactions in breastfed infants.
-Women should discontinue breastfeeding prior to initiating therapy and for 7 months after the last dose.

See references