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Immune globulin subcutaneous Pregnancy and Breastfeeding Warnings

Brand names: Cutaquig, Cuvitru, Hizentra, Vivaglobin, Xembify

Medically reviewed by Drugs.com. Last updated on Feb 16, 2024.

Immune globulin subcutaneous Pregnancy Warnings

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

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

Animal studies have not been performed. There are no controlled data in human pregnancy. Clinical experience with immunoglobulins suggests no harmful effects on pregnancy, the fetus, or the neonate are expected. Immune globulins cross the placenta, increasingly during the third trimester.

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

Immune globulin subcutaneous Breastfeeding Warnings

Caution is recommended.

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

Comments:
-Endogenous immunoglobulins are excreted in milk and may transfer protective antibodies to the neonate.
-Consider the developmental and health benefits of breastfeeding and the mother's clinical need for this medication against any potential adverse effects on the infant from the drug or the underlying maternal condition.

See references

See also

References for pregnancy information

  1. (2006) "Product Information. Vivaglobin (immune globulin subcutaneous)." *ZLB Bioplasma Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2018) "Product Information. Cuvitru (immune globulin subcutaneous)." Baxter Healthcare Corporation
  5. (2018) "Product Information. Hizentra (immune globulin subcutaneous)." CSL Behring LLC

References for breastfeeding information

  1. (2006) "Product Information. Vivaglobin (immune globulin subcutaneous)." *ZLB Bioplasma Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2018) "Product Information. Cuvitru (immune globulin subcutaneous)." Baxter Healthcare Corporation
  5. (2018) "Product Information. Hizentra (immune globulin subcutaneous)." CSL Behring LLC

Further information

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

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