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Immune globulin intravenous Pregnancy and Breastfeeding Warnings

Immune globulin intravenous is also known as: Bivigam, Carimune, Carimune NF, Flebogamma, Gamimune, Gamimune N 10%, Gamimune N 5%, Gammagard S/D, Gammaplex, Gammar IV, Gammar-P I.V., Gamunex, Iveegam En, Octagam, Panglobulin, Panglobulin NF, Panzyga, Polygam S/D, Privigen, Sandoglobulin, Venoglobulin-S 10%, Venoglobulin-S 5%

Medically reviewed on Nov 14, 2017

Immune globulin intravenous Pregnancy Warnings

Use is not recommended unless clearly needed.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Animal studies have not been performed. There are no controlled data in human pregnancy. Intact immune globulins cross the placenta increasingly after 30 weeks gestation. Clinical experience with immunoglobulins does not suggest a harmful effect on pregnancy or the fetus. When administered prior to delivery in mothers with immune thrombocytopenic purpura, the platelet response and clinical effect were similar in the mother and the neonate.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Immune globulin intravenous Breastfeeding Warnings

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

Excreted into human milk: Yes

Comments:
-Immunoglobulins excreted in milk may help protect neonates from pathogens with a mucosal portal of entry.

See references

References for pregnancy information

  1. "Product Information. Carimune (immune globulin intravenous)." CSL Behring, King of Prussia, PA.
  2. "Product Information. Octagam (immune globulin intravenous)." Octapharma USA, Centreville, VA.
  3. "Product Information. Gammaplex (immune globulin intravenous)." Bio Products Laboratory, Raleigh, NC.
  4. "Product Information. Flebogamma (immune globulin intravenous)." Grifols USA LLC, Los Angeles, CA.
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. "Product Information. Bivigam (immune globulin intravenous)." Biotest Pharmaceuticals Corporation, Boca Raton, FL.
  7. "Product Information. Privigen (immune globulin intravenous)." CSL Behring Canada Inc, Ottawa, IA.
  8. "Product Information. Gammagard S/D (immune globulin intravenous)." Baxter Healthcare Corporation, Deerfield, IL.
  9. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Carimune (immune globulin intravenous)." CSL Behring, King of Prussia, PA.
  2. "Product Information. Octagam (immune globulin intravenous)." Octapharma USA, Centreville, VA.
  3. "Product Information. Bivigam (immune globulin intravenous)." Biotest Pharmaceuticals Corporation, Boca Raton, FL.
  4. "Product Information. Gammagard S/D (immune globulin intravenous)." Baxter Healthcare Corporation, Deerfield, IL.
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. "Product Information. Privigen (immune globulin intravenous)." CSL Behring Canada Inc, Ottawa, IA.
  7. "Product Information. Gammaplex (immune globulin intravenous)." Bio Products Laboratory, Raleigh, NC.
  8. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  9. "Product Information. Flebogamma (immune globulin intravenous)." Grifols USA LLC, Los Angeles, CA.

Further information

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

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