Animal studies have not been conducted. There are no controlled data in human pregnancy. Clinical experience with other immunoglobulins during pregnancy suggest no adverse fetal effects.

Report infections to the manufacturer. Patients should immediately report symptoms of decreased urine output, sudden weight gain, and/or shortness of breath (which may suggest kidney damage) to their physician.

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.

This drug should be used during pregnancy only if clearly needed.

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

See references

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-Immunoglobulins are excreted in breast milk and may transfer protective antibodies to the neonate, but it is unknown if this applies to this drug.
-Clinical experience with immunoglobulins suggest no harmful effects on the neonate are to be expected.

See references