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Influenza virus vaccine, inactivated Pregnancy and Breastfeeding Warnings

Influenza virus vaccine, inactivated is also known as: Afluria, Afluria Preservative-Free Pediatric Quadrivalent, Afluria Preservative-Free Quadrivalent, Afluria Quadrivalent, FluLaval Preservative-Free Quadrivalent, Fluad, Fluad Preservative-Free, Fluad Preservative-Free Quadrivalent, Fluad Quadrivalent, Fluarix Preservative-Free Quadrivalent, Fluarix Quadrivalent, Flublok Quadrivalent, Flucelvax, Flucelvax Quadrivalent, Fluvirin Preservative-Free, Fluzone, Fluzone High-Dose, Fluzone High-Dose Quadrivalent, Fluzone Intradermal, Fluzone Intradermal Quadrivalent, Fluzone Preservative-Free, Fluzone Preservative-Free Pediatric, Fluzone Preservative-Free Pediatric Quadrivalent, Fluzone Preservative-Free Quadrivalent, Fluzone Quadrivalent

Medically reviewed by Drugs.com. Last updated on Aug 19, 2020.

Influenza virus vaccine, inactivated Pregnancy Warnings

Animal studies of administration prior to mating, during organogenesis, and later in pregnancy did not show vaccine-related fetal malformations or variations, and no adverse pre-weaning developmental effects. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

Pregnancy registries have been established for FLUARIX and FLULAVAL at 1-888-452-9622.

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.

Use is not recommended unless clearly needed.

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

Comments:
-Consult manufacturer information for specific pregnancy categories.
-There is no data on use in pregnant women to know this drugs risks.
-Pregnant patients with seasonal influenza are at increased risk of severe illness compared with non-pregnant patients, and are at increased risk of adverse pregnancy outcomes including preterm labor and delivery.

See references

Influenza virus vaccine, inactivated Breastfeeding Warnings

Caution is recommended.

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

See references

References for pregnancy information

  1. "Product Information. Fluad 2019-2020 (influenza virus vaccine, inactivated)." Seqirus, A CSL Company, Cambridge, MA.
  2. "Product Information. Fluarix PF Quadrivalent 2019-2020 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
  3. "Product Information. FluLaval Quadrivalent 2015-2016 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.

References for breastfeeding information

  1. "Product Information. Fluzone High-Dose 2015-2016 (influenza virus vaccine, inactivated)." sanofi pasteur, Swiftwater, PA.
  2. "Product Information. Fluzone Quadrivalent (influenza virus vaccine, inactivated)." Sanofi Pasteur, Toronto, IA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Flublok 2015-2016 (influenza virus vaccine, inactivated)." Protein Sciences Corporation, Meriden, CT.
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. "Product Information. FluLaval 2014-2015 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
  7. "Product Information. FluLaval Quadrivalent 2015-2016 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
  8. "Product Information. FluMist (influenza virus vaccine, live, trivalent)." Medimmune Inc, Gaithersburg, MD.
  9. "Product Information. Fluzone Intradermal 2014-2015 (influenza virus vaccine, inactivated)." sanofi pasteur, Swiftwater, PA.
  10. "Product Information. Fluarix 2014-2015 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
  11. "Product Information. Flucelvax 2015-2016 (influenza virus vaccine, inactivated)." Novartis Vaccines & Diagnostics Inc, Cambridge, MA.
  12. "Product Information. Agriflu (influenza virus vaccine, inactivated)." Novartis Pharmaceuticals, East Hanover, NJ.
  13. "Product Information. Fluarix Quadrivalent 2015-2016 (influenza virus vaccine, inactivated)." GlaxoSmithKline, Research Triangle Park, NC.
  14. "Product Information. Fluvirin 2015-2016 (influenza virus vaccine, inactivated)." Novartis Vaccines & Diagnostics Inc, Cambridge, MA.
  15. "Product Information. Afluria 2015-2016 (influenza virus vaccine, inactivated)." bioCSL Inc, King of Prussia, PA.

Further information

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