Animal studies have not been conducted. There are no controlled data in human pregnancy.

AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

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.

Safety has not been established during pregnancy; caution is recommended.
This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned

Comments:
-Routine use for rubella prophylaxis in early pregnancy is of dubious value and cannot be justified.
-Although this drug can prevent or modify clinical disease if given within 72 hours of rubella exposure, it does not prevent viremia, and cannot be relied upon to prevent congenital malformations due to rubella during the first trimester.
-Some studies suggest use in exposed, susceptible women may decrease the likelihood of infection and fetal damage, so it may benefit women who will not consider a therapeutic abortion.

See references

Caution is recommended.

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

Comments:
-Immunoglobulins are excreted in breast milk, however it is unknown if this applies to passively administered immune globulins.

See references