Diphtheria toxoid / haemophilus b conjugate (prp-omp) vaccine / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid Pregnancy and Breastfeeding Warnings

Brand names: Vaxelis

Medically reviewed by Drugs.com. Last updated on Aug 21, 2023.

Diphtheria toxoid / haemophilus b conjugate (prp-omp) vaccine / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid Pregnancy Warnings

Animal studies have not been reported. 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 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.

This drug is not indicated for use in individuals 5 years of age and older.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

See references

Diphtheria toxoid / haemophilus b conjugate (prp-omp) vaccine / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid Breastfeeding Warnings

This drug is not indicated for use in individuals 5 years of age and older.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-The effects in the nursing infant are unknown.
-No information is available on the clinical use of this drug during breastfeeding.

See references

Further information

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