Hyqvia Pregnancy Warnings
Use is not recommended unless clearly needed.
AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned
Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Immune globulins cross the placenta increasingly after 30 weeks gestation.
Animal studies have not been conducted with the Immune Globulin Infusion (Human) component of this drug. Animal studies with recombinant human hyaluronidase did not show adverse effects on pregnancy; in these studies maternal antibodies to recombinant human hyaluronidase were transferred to the offspring in utero. 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.
See references
Hyqvia Breastfeeding Warnings
This drug should be used only if clearly needed.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-In animal studies, maternal antibodies binding to recombinant human hyaluronidase were transferred to offspring during lactation.
-The effects of antibodies that bind to recombinant human hyaluronidase transferred during human lactation 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
