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Hepatitis b pediatric vaccine Pregnancy and Breastfeeding Warnings

Hepatitis b pediatric vaccine is also known as: Engerix-B Pediatric, Recombivax HB, Recombivax HB Pediatric/Adolescent

Medically reviewed on July 19, 2018

Hepatitis b pediatric vaccine Pregnancy Warnings

Use is not recommended unless clearly needed.

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

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.

See references

Hepatitis b pediatric 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

References for pregnancy information

  1. "Product Information. Recombivax HB Pediatric/Adolescent (hepatitis B pediatric vaccine)." Merck & Company Inc, West Point, PA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Engerix-B Pediatric (hepatitis B pediatric vaccine)." GlaxoSmithKline, Research Triangle Park, NC.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Briggs GG, Freeman RK, Yaffe SJ. "Drugs in Pregnancy and Lactation. 9th ed." Philadelphia, PA: Llippincott Williams & Wilkins (2011):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Recombivax HB Pediatric/Adolescent (hepatitis B pediatric vaccine)." Merck & Company Inc, West Point, PA.
  5. "Product Information. Engerix-B Pediatric (hepatitis B pediatric vaccine)." GlaxoSmithKline, Research Triangle Park, NC.

Further information

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

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