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Hepatitis b adult vaccine Pregnancy and Breastfeeding Warnings

Brand names: Engerix-B, Heplisav-B, PreHevbrio, Recombivax HB Adult, Recombivax HB Dialysis Formulation

Medically reviewed by Drugs.com. Last updated on Jul 20, 2023.

Hepatitis b adult vaccine Pregnancy Warnings

Animal studies have not been conducted. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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.

Use is not recommended unless clearly needed.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

See references

Hepatitis b adult vaccine Breastfeeding Warnings

A study in 12 lactating women did not show evidence of this vaccine being excreted in breast milk. The Centers for Disease Control and Prevention (CDC) state that the vaccine may be used during lactation.

Caution is recommended.

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

See references

See also

References for pregnancy information

  1. Product Information. Engerix-B (HepB) (hepatitis B adult vaccine). Apothecon Inc. 2022.
  2. Product Information. Recombivax HB (hepatitis B pediatric vaccine). Merck & Co., Inc. 2022.
  3. Cerner Multum, Inc. UK Summary of Product Characteristics.
  4. Cerner Multum, Inc. Australian Product Information.

References for breastfeeding information

  1. Product Information. Engerix-B (HepB) (hepatitis B adult vaccine). Apothecon Inc. 2022.
  2. Product Information. Recombivax HB (hepatitis B pediatric vaccine). Merck & Co., Inc. 2022.
  3. Cerner Multum, Inc. UK Summary of Product Characteristics.
  4. Cerner Multum, Inc. Australian Product Information.
  5. Briggs GG, Yaffe SJ., Freeman RK. Drugs in Pregnancy and Lactation. Philadelphia, PA: Llippincott Williams & Wilkins. 2011.

Further information

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

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