Flumist Quadrivalent: Uses, Side Effects and Dosage

What is FLUMIST QUADRIVALENT used for?

• FLUMIST QUADRIVALENT is a vaccine used to prevent the flu in people between 2 to 59 years of age.

How does FLUMIST QUADRIVALENT work?

FLUMIST QUADRIVALENT is a vaccine against the flu. The vaccine is made from strains of the flu that are expected to come within the next year in North America.

What are the ingredients in FLUMIST QUADRIVALENT?

Medicinal ingredients: Influenza vaccine (live, attenuated).

Non-medicinal ingredients: Arginine hydrochloride, dibasic potassium phosphate, gelatin hydrolysate (porcine Type A), gentamicin (a trace residual), monobasic potassium phosphate, monosodium glutamate, ovalbumin (a trace residual) and sucrose.

FLUMIST QUADRIVALENT contains no preservatives (e.g. no thimerosal). The intranasal sprayer contains no latex.

FLUMIST QUADRIVALENT comes in the following dosage forms:

FLUMIST QUADRIVALENT is a 0.2 mL spray for nasal administration.

Each 0.2 mL dose contains 10^6.5-7.5 FFU (fluorescent focus units) of live attenuated influenza virus reassortants of each of the four virus strains for the specific season. The four strains used for the 2024-2025 season are: A/Norway/31694/2022 (H1N1) (A/Victoria/4897/2022 (H1N1)pdm09-like virus), A/Thailand/8/2022 (H3N2), B/Phuket/3073/2013 (Yamagata lineage), and B/Austria/1359417/2021 (Victoria lineage).

Do not use FLUMIST QUADRIVALENT if you or your child(ren) have:

• Had an allergic reaction to gentamicin (a trace residual), gelatin, arginine or any of the other ingredients contained in FLUMIST QUADRIVALENT.
• Ever had a severe allergic reaction to eggs or egg proteins.
• Had an allergic reaction to previous flu vaccination.

To help avoid side effects and ensure proper use, talk to your or your child’s healthcare professional before you or your child(ren) take FLUMIST QUADRIVALENT. Talk about any health conditions or problems you may have, including if you or your child(ren):

• Are under the age of 18 years receiving aspirin or medicines containing aspirin.
• Have severe asthma or active wheezing.
• Have had Guillain-Barré syndrome with a previous flu shot.
• Are immunosuppressed due to disease or drug treatment, or associate with people who are immunosuppressed.

• Are pregnant or intend to become pregnant or are nursing.

Tell your or your child’s healthcare professional about all the medicines you or your child(ren) take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with FLUMIST QUADRIVALENT:

• if 2 to 17 years old: aspirin or medicines containing aspirin.
• prescription medicines used to treat flu.

How to take FLUMIST QUADRIVALENT:

FLUMIST QUADRIVALENT is given by healthcare professionals.

FLUMIST QUADRIVALENT is needle-free. FLUMIST QUADRIVALENT must only be used as a nasal spray. FLUMIST QUADRIVALENT must not be injected.

FLUMIST QUADRIVALENT is a gentle mist and will be given as a spray in each nostril. You can breathe normally while FLUMIST QUADRIVALENT is being given. There is no need to actively inhale or sniff.

Administration: FLUMIST QUADRIVALENT is administered by quickly spraying approximately one-half of the contents into each nostril. Please refer to the diagram below for simple step-by-step administration instructions. Once FLUMIST QUADRIVALENT has been administered, the sprayer should be disposed of according to the standard procedures for medical waste (e.g., sharps container or biohazard container).

Figure 1

Figure 2

Usual dose:

One 0.2 mL dose of FLUMIST QUADRIVALENT per year; about one-half of the contents will be sprayed into each nostril.

Children (2-8 years) who have not previously been vaccinated with the flu shot should receive a second dose 4 weeks after the first dose.

Overdose:

There is no relevant information available on overdose with FLUMIST QUADRIVALENT vaccine.

What are possible side effects from using FLUMIST QUADRIVALENT?

These are not all the possible side effects you or your child may have when taking FLUMIST QUADRIVALENT. If you or your child(ren) experience any side effects not listed here, tell your or your child’s healthcare professional.

Very common (occurs in more than 1 in 10 people)

• Children: runny or stuffy nose, reduced appetite, weakness, headache, and fever.

• Adults: runny or stuffy nose, headache, sore throat, weakness and cough.

Common (occurs in less than 1 in 10 people)

• Children: muscle aches
• Adults: chills

Uncommon (occurs in less than 1 in 100 people)

• rash
• nose bleed

Rare (occurs in less than 1 in 1,000 people)

• allergic reactions

Very rare (occurs in less than 1 in 10,000 people)

• Guillain-Barré syndrome

Unknown

• worsening of symptoms of Leigh syndrome

If you or your child(ren) have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your or your child’s healthcare professional.

Storage:

• FLUMIST QUADRIVALENT must be stored in a refrigerator (2°C – 8°C) upon receipt and until use. DO NOT FREEZE.
• Keep the nasal sprayer in the outer carton in order to protect from light.
• Use FLUMIST QUADRIVALENT before the expiry date on the sprayer label.

Keep out of reach and sight of children.

If you want more information about FLUMIST QUADRIVALENT:

• Talk to your or your child’s healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website: www.astrazeneca.ca, or by calling 1-800-668-6000.

FLUMIST^® is a registered trademark of MedImmune, LLC, used under license by AstraZeneca Canada Inc. The AstraZeneca logo is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc.

© AstraZeneca Canada Inc. 2024

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