Hepatitis b immune globulin Pregnancy and Breastfeeding Warnings
Brand names: BayHep B, H-BIG, HepaGam B, HepaGam B NovaPlus, Hyperhep, Hyperhep B, Nabi-HB, Nabi-HB Novaplus
Medically reviewed by Drugs.com. Last updated on Aug 16, 2023.
Hepatitis b immune globulin Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
AU TGA pregnancy category: Exempt
US FDA pregnancy category: C
Comments:
-There is no data on use in pregnancy to know this drugs risks, including the risk of fetal harm or reproductive effects.
Animal studies have not been performed. 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 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.
Hepatitis b immune globulin Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
See also
References for pregnancy information
- (2022) "Product Information. Nabi-HB (hepatitis B immune globulin)." Biotest Pharmaceuticals Corporation
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee (2010) Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm
References for breastfeeding information
- (2022) "Product Information. Nabi-HB (hepatitis B immune globulin)." Biotest Pharmaceuticals Corporation
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.