This drug should not be used during pregnancy unless clearly necessary and after careful consideration of the needs of the mother and the risk to the fetus.

US FDA pregnancy category: Not assigned.

Comments:
-This drug can cause fetal harm when administered to a pregnant woman.
-Verify the pregnancy status of females of reproductive potential prior to initiating therapy.
-Advise pregnant women and females of reproductive potential that exposure to this drug during pregnancy or within 4 months prior to conception can result in fetal harm.
-Advise females of reproductive potential to use effective contraception during treatment and 4 months after the last dose.
-Based on animals and the drug mechanism of action, this drug can cause fetal harm.

Postmarketing reports demonstrated that using a HER2-directed antibody during pregnancy resulted in oligohydramnios and oligohydramnios sequence cases, which manifested as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. In an animal reproduction study, the intravenous administration of 50 or 100 mg/kg once every 3 weeks to pregnant animals, starting at gestational day 20 until delivery, resulted in oligohydramnios and delayed infant kidney development. There are no controlled data on human pregnancy.

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.

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Published data suggest human IgG is present in human milk but does not enter the circulation of newborns or infants in substantial amounts. Because this drug is a large protein molecule with a molecular weight of about 149,000, the amount in milk is likely to be very low, and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. No information is available on this drug's presence in human milk, effects during breastfeeding, or milk production.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and any potential adverse effects on the breastfed child.

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

Comments:
-The effects on the nursing infant are unknown.
-Nursing women should consider that it takes 4 months for the drug to be eliminated from the body.

See references