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Influenza virus vaccine, inactivated Pregnancy and Breastfeeding Warnings

Influenza virus vaccine, inactivated is also known as: Afluria, Afluria Quadrivalent, FluLaval, FluLaval Quadrivalent, Fluad, Fluad 2017-2018, Fluarix, Fluarix Quadrivalent, Flublok, Flublok Quadrivalent, Flucelvax, Flucelvax Quadrivalent, Fluvirin, Fluvirin Preservative-Free, Fluzone, Fluzone High-Dose, Fluzone High-Dose 2017-2018, Fluzone Intradermal, Fluzone Intradermal Quadrivalent, Fluzone Preservative-Free, Fluzone Preservative-Free Pediatric, Fluzone Preservative-Free Pediatric Quadrivalent, Fluzone Preservative-Free Quadrivalent, Fluzone Quadrivalent, Fluzone Quadrivalent 2017-2018

Medically reviewed on Aug 10, 2018

Influenza virus vaccine, inactivated Pregnancy Warnings

Animal studies did not show effects on pregnancy, embryo-fetal development, postnatal development, or fertility. There are no controlled data in human pregnancy. Limited post-marketing data do not indicate adverse fetal or maternal outcomes.

A pregnancy registry has been established in the US for women receiving FLULAVAL(R), FLUARIX(R), or FLUARIX QUADRIVALENT(R) flu vaccine at 1-888-452-9633, for Flublock(R) at 1-888-855-7871, or for Fluzone(R) (all formulations) at 1-800-822-2463

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.

Use is not recommended unless clearly needed.

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

Comments:
-Pregnant women, particularly during the second and third trimester, are at increased risk of influenza related complications.
-Vaccination before pregnancy and/or flu season is recommended.

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

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