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Immune globulin intravenous and subcutaneous Pregnancy and Breastfeeding Warnings

Immune globulin intravenous and subcutaneous is also known as: Gammagard, Gammaked, Gamunex-C

Medically reviewed on Nov 6, 2018

Immune globulin intravenous and subcutaneous Pregnancy Warnings

Safety has not been established during pregnancy; use during pregnancy only if clearly needed.

US FDA pregnancy category: Not assigned

Animal studies have not been conducted. There are no controlled data in human pregnancy. Immune globulin intravenous only crosses the human placenta in significant amounts after 32 weeks gestation; placental transfer is a function of both dose and gestational age.

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 decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Immune globulin intravenous and subcutaneous Breastfeeding Warnings

Safety has not been established.

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

See references

References for pregnancy information

  1. "Product Information. Gamunex-C (immune globulin intravenous and subcutaneous)." Talecris Biotherapeutics, Research Triangle Park, NC.
  2. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

References for breastfeeding information

  1. "Product Information. Gamunex-C (immune globulin intravenous and subcutaneous)." Talecris Biotherapeutics, Research Triangle Park, NC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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