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Immune globulin intramuscular Pregnancy and Breastfeeding Warnings

Brand names: BayGam, Biogam, GamaSTAN S/D

Medically reviewed by Drugs.com. Last updated on Feb 17, 2025.

Immune globulin intramuscular Pregnancy Warnings

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.

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.

See references

Immune globulin intramuscular Breastfeeding Warnings

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

See also

References for pregnancy information

  1. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee (2007) Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. http://www.tga.gov.au/docs/pdf/medpreg.pdf
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2018) "Product Information. Gamastan S/D (immune globulin intramuscular)." Grifols Therapeutics

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information."
  2. (2018) "Product Information. Gamastan S/D (immune globulin intramuscular)." Grifols Therapeutics

Further information

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

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