Japanese encephalitis vaccine SA14-14-2, inactivated Pregnancy and Breastfeeding Warnings

Brand names: Ixiaro

Medically reviewed by Drugs.com. Last updated on Jan 3, 2025.

Japanese encephalitis vaccine SA14-14-2, inactivated Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: Use should be avoided.
-According to some authorities: Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk summary: Inadequate data available on the use of this drug in pregnant women to inform a drug-related risk.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Japanese encephalitis vaccine SA14-14-2, inactivated Breastfeeding Warnings

Caution is recommended

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

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.

See references

Further information

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