Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Preclinical studies revealed no evidence of adverse developmental outcomes following the intravenous administration of efgartigimod alfa up to 100 mg/kg/day.

Comments:
-As pregnancy progresses, the transportation of monoclonal antibodies through the placenta becomes more frequent, with the largest amount transferred during the third trimester. Consequently, there is a possibility for this drug to be transmitted from the mother to the developing fetus.
-Due to its expected effect on reducing maternal IgG antibody levels, this drug product is likely to decrease passive protection provided to the newborn. Therefore, before administering live or live-attenuated vaccines to infants who were exposed to this drug product during pregnancy, it is essential to carefully evaluate the risks and benefits.

Efgartigimod alfa:
-Intravenous administration of this drug at various doses (0, 30, or 100 mg/kg/day) during pregnancy in rats and rabbits showed no harmful effects on the development of embryos and fetuses.
-The highest doses administered to the mothers were about 8 and 62 times higher, respectively, than the recommended human dose of 1008 mg.
-Similarly, when administered to rats throughout pregnancy and lactation, this drug did not have any negative effects on the pre- or postnatal development of offspring. The highest dose given to the mothers was approximately 13 times higher than the recommended human dose.

Hyaluronidase:
-When pregnant mice were given hyaluronidase (recombinant human) through subcutaneous injection during organogenesis, it resulted in increased mortality of embryos and fetuses, as well as reduced fetal body weights at the highest doses used.
-The dosage at which no adverse effects on embryofetal development were observed in mice was about 1800 times higher than the recommended human dose of hyaluronidase in this drug product (which contains 1,008 mg efgartigimod alfa and 11,200 U hyaluronidase).
-However, when hyaluronidase (recombinant human) was subcutaneously administered to mice throughout gestation and lactation, no negative effects were observed on the development of offspring, even at doses up to 5,000 times higher than the recommended human dose of hyaluronidase in this drug product, on a U/kg basis.

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.

See references

Safety has not been established. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects on the breastfed child from this drug or from the underlying maternal condition.

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

Comments:
-The effects in the nursing infant are unknown.
-Maternal IgG is known to be excreted in human milk.

See references