"The U.S. Food and Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the preve"...
(pronounced FLEW-mist Kwä-dre-VA-lent)
(Influenza Vaccine Live, Intranasal)
Please read this Patient Information carefully before you or your child is vaccinated with FluMist Quadrivalent.
This is a summary of information about FluMist Quadrivalent. It does not take the place of talking with your healthcare provider about influenza vaccination. If you have questions or would like more information, please talk with your healthcare provider.
What is FluMist Quadrivalent?
FluMist Quadrivalent is a vaccine that is sprayed into the nose to help protect against influenza. It can be used in children, adolescents, and adults ages 2 through 49. FluMist Quadrivalent is similar to MedImmune's trivalent Influenza Vaccine Live, Intranasal (FluMist) except FluMist Quadrivalent provides protection against an additional influenza strain. FluMist Quadrivalent may not prevent influenza in everyone who gets vaccinated.
Who should not get FluMist Quadrivalent?
You should not get FluMist Quadrivalent if you:
- have a severe allergy to eggs or to any inactive ingredient in the vaccine (see “What are the ingredients in FluMist Quadrivalent?”)
- have ever had a life-threatening reaction to influenza vaccinations
- are 2 through 17 years old and take aspirin or medicines containing aspirin. Children or adolescents should not be given aspirin for 4 weeks after getting FluMist or FluMist Quadrivalent unless your healthcare provider tells you otherwise.
Please talk to your healthcare provider if you are not sure if the items listed above apply to you or your child.
Children under 2 years old have an increased risk of wheezing (difficulty with breathing) after getting FluMist Quadrivalent.
Who may not be able to get FluMist Quadrivalent?
Tell your healthcare provider if you or your child:
- are currently wheezing
- have a history of wheezing if under 5 years old
- have had Guillain-Barré syndrome
- have a weakened immune system or live with someone who has a severely weakened immune system
- have problems with your heart, kidneys, or lungs
- have diabetes
- are pregnant or nursing
- are taking Tamiflu®, Relenza®, amantadine, or rimantadine
If you or your child cannot take FluMist Quadrivalent, you may still be able to get an influenza shot. Talk to your healthcare provider about this.
How is FluMist Quadrivalent given?
- FluMist Quadrivalent is a liquid that is sprayed into the nose.
- You can breathe normally while getting FluMist Quadrivalent. There is no need to inhale or “sniff” it.
- People 9 years of age and older need one dose of FluMist Quadrivalent each year.
- Children 2 through 8 years old may need 2 doses of FluMist Quadrivalent, depending on their history of previous influenza vaccination. Your healthcare provider will decide if your child needs to come back for a second dose.
What are the possible side effects of FluMist Quadrivalent?
The most common side effects are:
Other possible side effects include:
- decreased appetite
- muscle ache
Call your healthcare provider or go to the emergency department right away if you or your child experience:
- hives or a bad rash
- trouble breathing
- swelling of the face, tongue, or throat
These are not all the possible side effects of FluMist Quadrivalent. You can ask your healthcare provider for a complete list of side effects that is available to healthcare professionals.
Call your healthcare provider for medical advice about side effects. You may report side effects to VAERS at 1-800-822-7967 or http://vaers.hhs.gov.
What are the ingredients in FluMist Quadrivalent?
Active Ingredient: FluMist Quadrivalent contains 4 influenza virus strains that are weakened (A(H1N1), A(H3N2), B Yamagata lineage, and B Victoria lineage).
Inactive Ingredients: monosodium glutamate, gelatin, arginine, sucrose, dibasic potassium phosphate, monobasic potassium phosphate, and gentamicin.
FluMist Quadrivalent does not contain preservatives.
How is FluMist Quadrivalent Stored?
FluMist Quadrivalent is stored in a refrigerator (not the freezer) between 35-46 degrees F (2-8 degrees C) upon receipt. FluMist Quadrivalent sprayer must be kept in the carton until use in order to protect from light. FluMist Quadrivalent must be used before the expiration date on the sprayer label.
If you would like more information, talk to your healthcare provider or visit www.flumistquadrivalent.com or call 1-877-633-4411.
Last reviewed on RxList: 10/20/2016
This monograph has been modified to include the generic and brand name in many instances.
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