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Japanese enceph vacc sa14-14-2, inactivated Pregnancy and Breastfeeding Warnings

Brand names: Ixiaro

Medically reviewed by Drugs.com. Last updated on Jan 3, 2024.

Japanese enceph vacc sa14-14-2, inactivated Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Animal studies at doses about 300-fold the human dose show no fertility impairment or fetal harm. Embryo-fetal and pre-weaning developmental studies comparing giving this vaccine twice prior to gestation and once during organogenesis (gestation day 6 in rats) (3 dose group) to administering once prior to gestation and again at organogenesis (2 dose group), at intramuscular doses about 300-fold the human dose showed no adverse effects on mating, fertility, pregnancy, parturition, lactation, embryofetal or pre-weaning development, but a statistically significant number of fetuses in the 2 dose group had incomplete ossification, but data do not suggest this is vaccine related. No vaccine related fetal malformations or other teratogenicity was seen. There are no controlled data in human pregnancy.

Healthcare providers are encouraged to report inadvertent exposure during pregnancy to the manufacturer.

AU TGA pregnancy category B1: 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 have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Japanese enceph vacc sa14-14-2, inactivated Breastfeeding Warnings

Embryo-fetal and pre-weaning developmental studies comparing giving this vaccine twice prior to gestation and once during organogenesis (gestation day 6 in rats) (3 dose group) to administering once prior to gestation and again at organogenesis (2 dose group), at intramuscular doses about 300-fold the human dose showed no adverse effects on mating, fertility, pregnancy, parturition, lactation, embryofetal or pre-weaning development, but a statistically significant number of fetuses in the 2 dose group had incomplete ossification, but data do not suggest this is vaccine related.

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. Ixiaro (Japanese enceph vacc SA14-14-2, inactivated). Valneva USA. 2022.
  2. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm 2010.

References for breastfeeding information

  1. Product Information. Ixiaro (Japanese enceph vacc SA14-14-2, inactivated). Valneva USA. 2022.

Further information

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

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