Safety has not been established; use should be avoided as a precautionary measure.

US FDA pregnancy category: Not assigned.

Risk summary: Human immunoglobulin G (IgG) antibodies are known to cross the placenta; therefore, this drug may be transmitted from the mother to the fetus.

Comments:
-There is limited data on use in pregnant women to know the risks, including the risk of fetal harm or reproductive effects.

Animal studies have failed to reveal evidence of fetal harm. A pre- and post-natal study in monkeys showed no maternal or embryofetal toxicity when administering IV doses of this drug up to 10 times the maximum recommended human dose, every week starting from gestation day 20. Infants were observed from birth through 6 months of age showing no treatment-related adverse effects. There are no controlled data in 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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Because this drug is a large protein molecule, the amount in milk is likely to be very low. In addition, the infant's gastrointestinal tract may partially destroy this drug; absorption by the infant is probably minimal.

LactMed: Caution is recommended, especially while breastfeeding newborn or preterm infants.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue this drug, considering the importance of this therapy to the mother, and the benefit of breastfeeding for the child.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Maternal immunoglobulin G (IgG) is present in breast milk, however, the effects of local gastrointestinal exposure and limited systemic exposure to this drug on the breastfed infant are unknown.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references